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<h3>Job Description</h3>
Job Description
As a global organization, PharmEng Technology has been providing quality services to leading manufacturers of the Pharmaceutical and Biotech industries since 1997. Our employees come from diverse backgrounds where we value unique talents and work together to support our clients. In addition, our consultants have extensive experience obtained from world-class organizations across the globe, and the development of our staff continues to grow PharmEng Technology.
We are seeking an experienced Validation Engineer in Dorado, Puerto Rico. 
Objectives of this Role:
<ul>
<li>Write and execute, Installation Qualification (IQ), and Operational Qualification (OQ) protocols and Summary Reports including thorough resolution of protocol discrepancies.</li>
<li>Assess potential sources of variation in materials, processes, facilities, equipment, products, and packaging processes that may impact consistent performance or product quality; where needed, design studies to characterize impact of identified sources.</li>
<li>Maintain an up-to-date knowledge of validation requirements, practices, and procedures.</li>
<li>Interpret existing Validation Plans and Project Plans and apply concepts to the task at hand.</li>
<li>Working with a team to ensure all aspects of activity within the Process Development and Validation group adhere to required policies and procedures, including safety and training.</li>
<li>Investigate/troubleshoot validation problems, as well as, conduct some statistical analysis of testing results.</li>
</ul>
Skills and Qualifications:
<ul>
<li>• More than 5 years of experience in the industry (preferably with experience in medical devices). • Experience executing semi-automatic equipment validations (Debug, IQ/SQ, Process Characterization, OQ/PQ, etc.). </li>
<li>• Technical knowledge.</li>
<li> • Knowledge of software and/or PLC is an advantage.</li>
<li> • The candidate must be committed to the project and work in person daily. Distance should not represent a risk of abandoning the project early.</li>
<li> • Willing to work overtime or weekends if necessary. </li>
</ul>
Our Benefits:
<ul>
<li>Health, Dental, and Vision Insurance Benefits</li>
<li>Training Opportunities and Career Development</li>
<li>401k plan with Employer Contributions</li>
</ul>
PharmEng Technology is committed to attracting and retaining world-class employees valued for their contributions to achieving business objectives. PharmEng offers continuous career growth, competitive wages, travel opportunities, a team mentality that sets us apart from our competitors, and more!

Validation Engineer

<h3>Job Description</h3>
Job DescriptionQuality Inspector - 2nd shift 
Responsibilities:
<ul>
<li>Read blueprints and drawings to understand specifications and tolerances for parts.</li>
<li>Inspect and measure machined component parts and incoming materials using hard gauges, hand tools, and other equipment to ensure compliance with specifications.</li>
<li>Perform inspections in receiving, in-process, and final stages.</li>
<li>Complete and submit required inspection documentation, labels, and electronic transactions.</li>
<li>Suggest improvements to inspection processes and methods.</li>
<li>Collaborate with cross-functional teams to communicate quality standards and expectations.</li>
<li>Assist in meeting goals related to quality, cost, and delivery.</li>
<li>Operate in compliance with safety and quality standards.</li>
<li>Uphold the organization's quality policy and commitment to customer satisfaction.</li>
<li>Perform other duties as required.</li>
</ul>
Qualifications:
<ul>
<li>Experience with inspection tools such as calipers, micrometers, and CMM.</li>
<li>Ability to read and interpret blueprints and technical drawings.</li>
<li>Strong attention to detail and problem-solving skills.</li>
<li>Excellent communication and teamwork abilities.</li>
<li>Commitment to safety and quality standards.</li>
</ul>
Apply Now
Pay and Benefits
The pay range for this position is $52000.00 - $72800.00/yr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental &amp; vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life &amp; AD&amp;D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Maple Grove,MN.
Application Deadline
This position is anticipated to close on Aug 25, 2025.
About Aerotek:
We know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meets their goals, skills and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role solving for companies’ construction, manufacturing and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are everything spirit to the test as your career continues to grow.
Aerotek offers weekly pay, employee benefits including medical, dental &amp; vision, life insurance, health advocacy and employee assistance programs, a 401(k) plan, and employee discounts.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Company DescriptionWe know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meet their goals, skills, and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role in solving companies’ construction, manufacturing, and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are-everything spirit to the test as your career continues to grow. 
<h3>Company Description</h3>
We know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meet their goals, skills, and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role in solving companies’ construction, manufacturing, and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are-everything spirit to the test as your career continues to grow.

Quality Inspector

<h3>Job Description</h3>
Job Description
About the Company
O'Fallon Casting is a global leader in the production of high-quality aluminum alloy investment castings. Since 1969, our family-owned company has been dedicated to delivering precision-engineered solutions for the aerospace, defense, and commercial markets. Operating from our modern 75,000-square-foot foundry in O'Fallon, Missouri, we specialize in complex, castings that meet the rigorous demands of the world's leading aerospace and defense contractors. Our constructive culture fosters innovation, collaboration, and excellence, ensuring that we remain at the forefront of the industry. Please consider joining our growing team
Supplier Quality Specialist
Responsibilities
<ul>
<li>The position is responsible for participating in the development and maintenance of Supplier Quality Assurance initiatives and processes and for supporting Strategic Sourcing in the overall supplier management</li>
<li>Execute the delegation program with suppliers to allow self-inspections and continually supply products at a high level of performance for Quality and Delivery</li>
<li>Execute supplier development activities with new suppliers</li>
<li>Participate in supplier process review including risk assessment</li>
<li>Drive supplier Improvement plans for low performing suppliers and run periodic focus reviews between suppliers and company management</li>
<li>Ensure supplier compliance to PO flow down and supplier Quality Manual requirements</li>
<li>Conduct supplier on-site and virtual audits per AS9100/ ISO 9001 requirements</li>
<li>Co-lead containment activities between Supplier and company on supplier escapes</li>
<li>Lead effective Root Cause Corrective Action for assigned Supplier Corrective actions (SCAR's) with suppliers to closure</li>
<li>Review and Approve Supplier First Article Inspection (FAI)</li>
<li>Assist suppliers with any non-conformance in FAI reporting</li>
<li>Assist in maintaining the company Approved Supplier List (APL)</li>
<li>Report monthly / Quarterly supplier performance data to supply base and company</li>
<li>Update and Maintain Supplier Quality KPI's on monthly basis</li>
<li>Coordinate with Purchasing and company when source inspection is required to either perform the inspection or arrange for subcontract source provider</li>
</ul>
 
Qualifications
<ul>
<li>Bachelor's Degree or the equivalent combination of related education, training, and experience with a minimum of 3-5 years of experience in a related position with experience in AS9100 / ISO 9001 Quality management system</li>
<li>2-3 years Auditing experience in AS9100 / ISO 9001 Quality Systems</li>
<li>Working Knowledge of Root Cause Corrective Action (RCCA) methodology which includes 8D, 5 whys and Fishbone diagrams</li>
<li>Working knowledge of quality tools such as FMEA, Control plans, SPC and Gage R&amp;R</li>
<li>Working knowledge of casting, machining, and finishing processes</li>
<li>Experience in developing and approving First Article Inspections (FAI)</li>
<li>Ability to interpret Drawings and Industry Specifications</li>
<li>Ability to understand and communicate machining process plans</li>
<li>Familiar with CAD, Solidworks preferred</li>
<li>Excellent communication skills and be able to communicate clearly and professionally, both orally and in writing</li>
<li>Ability to author reports, business correspondence, work instructions and procedure manuals</li>
</ul>

Supplier Quality Specialist

<h3>Job Description</h3>
Job Description
Summary
CTC Group is seeking&nbsp;Radio Frequency Engineers, levels 1-3,&nbsp;to perform board-level hardware and software design to include designing RF components, develop design plans, create drawings and schematics, research parts or equipment, analyze and troubleshoot problems, develop test procedures for specification compliance, test hardware at the system, subsystem, and component level, establish and maintain/update documentation of technical processes and procedures, and create and maintain documentation of system, subsystem, or equipment related to the design, development, testing, and verification of customized products. Locations: Annapolis Junction / Ft. Meade
Responsibilities
<ul>
<li>Evaluates engineering materials including detecting deviations and recommending solutions.</li>
<li>Designs RF module-based systems, test plans for RF relay systems, and the RF portion of specialized RF/digital board-level solutions.</li>
<li>Shares design requirements and restrictions of RF systems and related propagation with other design engineers during collaboration efforts.</li>
<li>RF and analog circuit designs implementing low-noise phase-locked-loop circuits and synthesizers, wideband automatic gain control (AGC) circuits, RF switching and control circuits, filters, low-noise high-efficiency power supplies, modulators, demodulators, RF power detection, frequency conversion, adaptive threshold, and low-distortion driver amplifiers.</li>
<li>Design, simulation, integration, and sustainment of Software Design Radio (SDR) systems to include, modem signal processing components, command-and-control / tasking systems, front-end components, documentation, and prototype software deployment systems</li>
<li>Circuit designs implementing microwave filters, oscillators, synthesizers, switches, and the cost/performance tradeoffs associated with these types of circuits.</li>
<li>Circuit designs implementing transmitters or receivers or amplifiers or software defined radios (SDRs) or Monolithic microwave integrated circuit (MMIC) components including antenna design/characterization while using VSWR to understand antenna performance.</li>
<li>Miniaturized, low-power receiver designs ranging in frequencies from High Frequency (HF) to C-Band.</li>
<li>Circuit designs using commercially available technologies for microwave filters, oscillators, synthesizers, and switches.</li>
<li>RF link budget and RF system analysis and cost estimate development for prototype and production efforts.</li>
<li>EMI requirements development and incorporation which includes filtering and shielding in the design to ensure performance.</li>
</ul>
Requirements
<ul>
<li>Active TS/SCI with polygraph security clearance</li>
<li>Bachelor's degree in electrical, electronic, or computer engineering; systems engineering; physics; mathematics; telecommunications; or computer science.</li>
</ul>
Level 1 Qualifications
<ul>
<li>Five (5) years of experience in Radio Frequency (RF), microwave, analog or SDR design.</li>
</ul>
Level 2 Qualifications
<ul>
<li>Seven (7) years of experience in Radio Frequency (RF), microwave, analog or SDR design.</li>
</ul>
Level 3 Qualifications
<ul>
<li>Ten (10) years of experience in Radio Frequency (RF), microwave, analog or SDR design.</li>
</ul>
 Pay Information The final salary may be influenced by various factors, such as location, labor categories, experience, education, and/or certifications. CTC also provides a variety of benefits as well as opportunities for continuous education and development.&nbsp; The estimated salary range for this position is $165,000 - $200,000. #CJ
Why CTC Group?
As a Service-Disabled Veteran-Owned Small Business (SDVOSB), we recognize that successful partnerships are based on open and direct communication, mutual respect, and the ability to adapt to evolving capabilities. Our cleared employees bring decades of experience supporting customers in the Intelligence and Defense communities. We specialize in providing engineering, technical, operational support, and training services to Federal government, and Mission Operations.
CTC Group provides a comprehensive benefits package that includes, but is not limited to, Health/Dental/Vision, 401k, PTO and holiday pay, disability and life insurance. To learn more about our benefits, click here.
CTC Group provides equal employment opportunities to all employees and applicants without regard to race, color, religious creed, sex, national origin, ancestry, citizenship status, pregnancy, physical disability, genetic information, mental disability, age, military status or status as a Vietnam-era or special disabled veteran, marital status, registered domestic partner status, gender (including sex stereotyping), medical condition (including, but not limited to, cancer related or HIV/AIDS related) or sexual orientation in accordance with applicable federal and state laws. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
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Radio Frequency Engineer

<h3>Job Description</h3>
Job Description
PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning and Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.
Job required Qualification:
<ul>
<li>Bachelor of Science degree, Engineering, or Equivalent training and experience.</li>
<li>More than 5 years of experience in a regulated environment.</li>
<li>3 years of experience authorizing procedural and commercial marketing documents.</li>
<li>More than 3 years of experience with clean rooms, aseptic suites, single-use technology, bioreactors, and cell culture.</li>
<li>Experience in mechanic and Industrial engineering </li>
<li>Strong working knowledge of pharmaceutical industry regulations (GMP, GDP, ICH, etc.)</li>
<li>Strong understanding and working knowledge of project lifecycle, entrepreneurial mindset, and excellent written and verbal communication skills.</li>
<li>Strong relationship management, leadership, and organizational skills.</li>
<li>Strong working knowledge in Microsoft suites, and Smartsheet.</li>
</ul>
Job responsibilities and Duties:
<ul>
<li>Develop and execute equipment qualification protocols for all manufacturing, processing, and packaging equipment and facilities/utilities supporting these operations.</li>
<li>Develop and execute process validation protocols for all manufacturing and packaging processes of commercial products (and R&amp;D products as applicable).</li>
<li>Develop and execute validation/verification protocols for all commercial and R&amp;D manufacturing, processing, and packaging equipment.</li>
<li>Analyze data, utilizing statistical methods, generated by validation studies performed by the Validation group to determine process capabilities.</li>
<li>Gather photocopies and compile relevant documentation such as executed batch records, certificates of analysis, equipment logs, equipment qualifications, raw material certificates of analysis.</li>
<li>Investigate and resolve deviations/exceptions from the predefined acceptance criteria.</li>
<li>Draw conclusions from data, observations, deviation/exception, and investigation as to whether the process is considered valid.</li>
<li>Write summary reports (closeout report when applicable) for validation/qualification protocols following criteria as outlined within the validation/qualification procedures and policies.</li>
<li>Maintain protocols and system documentation in an orderly library so that information can be provided to regulatory bodies in a timely manner.</li>
<li>Ensure protocols, verifications, validation plans, and summary reports generated during validation/ qualification activities are stored according to the procedure.</li>
<li>Maintain current knowledge in the areas of compliance and validation and other regulatory issues that may impact the Company. Work proactively to maintain the highest level of compliance in all areas. Gather current knowledge from QA/QC, regulatory, periodicals, and/or appropriate training programs.</li>
<li>Interact and coordinate compliance efforts with other departments including, but not limited to, Operations, Engineering, QA, laboratories (QC and R&amp;D), and R&amp;D to provide a high degree of assurance that all qualification/validation activities, where appropriate, are completed.</li>
<li>Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.</li>
<li>Perform other related duties as assigned to meet departmental and Company objectives.</li>
</ul>

<h3>Job Description</h3>
Job Description
Job Description:
We are seeking a skilled CNC Machinist with strong lathe setup experience to join our manufacturing team. In this role, you will be responsible for setting up, operating, and maintaining CNC lathes to produce precision components according to specifications. The ideal candidate will have experience reading technical drawings, selecting appropriate tooling, and performing quality checks to ensure product accuracy and consistency.
Key Responsibilities:
<ul>
<li>Set up and operate CNC lathes for production runs</li>
<li>Interpret blueprints, technical drawings, and work instructions</li>
<li>Select and install tools, fixtures, and machine attachments</li>
<li>Monitor machining processes and make adjustments as needed</li>
<li>Inspect finished parts using precision measuring tools</li>
<li>Perform routine maintenance and troubleshoot machine issues</li>
<li>Maintain a clean and safe work environment</li>
</ul>
Qualifications:
<ul>
<li>2+ years of CNC lathe setup and operation experience</li>
<li>Proficient in reading blueprints and using measuring instruments (micrometers, calipers, etc.)</li>
<li>Strong attention to detail and problem-solving skills</li>
<li>Ability to work independently and in a team environment</li>
</ul>

CNC Machinist

<h3>Job Description</h3>
Job Description
Kinetico is looking for a Quality Engineer to join our Newbury Operations team! 
The Quality Engineer supports the implementation and maintenance of quality control programs, ensuring products, services, and production methods meet Kinetico’s established standards. This role collaborates with various teams to drive continuous improvement and adherence to quality standards.
Key Responsibilities:
<ul>
<li>Assist in maintaining the Quality Management System (QMS), ensuring compliance with national and international standards.</li>
<li>Oversee corrective action processes and coordinate with cross-functional teams to resolve quality issues.</li>
<li>Utilize problem-solving methodologies, such as Lean or Six Sigma, to identify and implement process improvements.</li>
<li>Collaborate with production and engineering teams to support product launches and maintain consistent quality output.</li>
<li>Train and mentor quality technicians and team members on quality standards, procedures, and best practices.</li>
<li>Support audits (internal, external, supplier, ISO), collecting evidence and preparing reports to ensure compliance and system effectiveness.</li>
<li>Manage quality documentation, including control of records, forms, and work instructions.</li>
<li>Supervise day-to-day quality control operations, including inspections of incoming materials, in-process products, and finished goods.</li>
</ul>
This list of responsibilities is not exhaustive. Other duties may be required to be undertaken which fall within the scope and general level of responsibility attached to the role.
What you will need to succeed:
Education &amp; Qualifications:
<ul>
<li>Bachelor’s Degree in Engineering or related field preferred; equivalent experience considered.</li>
<li>Minimum 5 years of experience in quality assurance/control, preferably in manufacturing.</li>
<li>Experience with quality standards such as ISO 9001.</li>
<li>Strong analytical and problem-solving skills.</li>
<li>Proficiency in quality tools and methodologies (e.g., root cause analysis, Six Sigma, Lean).</li>
<li>Excellent written and verbal communication skills.</li>
<li>Proficiency in MS Office Suite (Excel, Word, PowerPoint).</li>
<li>Strong organizational skills with attention to detail.</li>
<li>Ability to train and mentor team members effectively.</li>
<li>Familiarity with ERP systems is a plus.</li>
</ul>
Competencies:
<ul>
<li>Balancing quality improvement initiatives with production schedules.</li>
<li>Managing quality issues while maintaining positive relationships.</li>
<li>Ensuring team adherence to quality standards amidst tight deadlines and high-pressure situations.</li>
<li>Implementing process improvements with minimal disruption to operations.</li>
<li>Training and upskilling team members on evolving quality standards and tools.</li>
</ul>
Compensation: 
<ul>
<li>Salaried, Non-Exempt</li>
</ul>
Travel:
<ul>
<li>None </li>
</ul>
Location:
<ul>
<li>Newbury, OH </li>
</ul>
Why Join Kinetico:
<ul>
<li>Medical, Dental, Vision and Prescription Drug Insurance Coverage </li>
<li>Employer Provided Life Insurance, Short-Term and Long-Term Disability Benefits</li>
<li>401(k) Contribution Matching Program</li>
<li>Employer Funded Defined Contribution Plan</li>
<li>Paid Vacation, Holidays and Community Service Volunteer Time-off Benefit </li>
<li>Wellness Program</li>
<li>Educational Assistance Reimbursement Program</li>
</ul>
Our Commitment and Difference: 
Founded in 1970, Kinetico was started by two engineers who pioneered the development of non-electric, fully automatic water treatment systems. Evolving from the Tangent Company, a small consulting design firm, Kinetico soon became a global organization of independent dealers, international distributors representing nearly 100 countries. Through the dedication of its founders, employees and distribution network, Kinetico has experienced tremendous success. The company has grown from a two-man, creative undertaking into a strong and dynamic organization.
Innovative technology and a strong commitment to customer satisfaction have distinguished the company and positioned Kinetico as a leader in today’s ever-changing water treatment industry manufacturing water softeners, along with a wide range of systems that improve water quality for general use, as well as those that provide high-quality drinking water for consumption. Kinetico products are Third Party certified to confirm quality and performance and complimented by the most comprehensive warranties in the industry.
Kinetico is part of the Axel Johnson Group of companies, a global organization and fifth generation company that continues to be successful in developing leading businesses.
Kinetico Incorporated is an Equal Employment Opportunity (EEO) employer and does not discriminate on the basis of race, color, national origin, religion, gender, age, veteran status, political affiliation, sexual orientation, marital status or disability (in compliance with the Americans with Disabilities Act*), or any other legally protected status, with respect to employment opportunities.
E-Verify: We verify the identity and employment authorization of individuals hired for employment in the United States.

Quality Engineer

<h3>Job Description</h3>
Job Description
Validation &amp; Engineering Group, Inc. (V&amp;EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
<ul>
<li>Sr. Quality Engineer</li>
</ul>
Qualifications:
<ul>
<li>Must have fundamental knowledge/experience in statistics, SPC, validation activities, Installation Qualification, Operation Qualification, Performance Qualification and Product Performance Qualification.</li>
<li>Knowledge in DOE, Six Sigma, and product transfer.</li>
<li>Must be knowledgeable of GMP and ISO evidenced by successful completion of training in GMP and, auditing principals.</li>
<li>Prior experience auditing FDA regulations.</li>
<li>Bilingual (English and Spanish), possess good communication and analytical skills, and availability to work under deadlines.</li>
<li>Credentials of a Certified Quality Engineer are a plus.</li>
<li>Able to apply comprehensive knowledge of a particular field of specialization to the completion of assigned task.</li>
<li>This is an onsite role.</li>
<li>Bachelor’s degree in Engineering (Industrial, or CQE preferred), advanced degree or process towards advanced degree is a plus.</li>
<li>A minimum of (7) seven years’ experience in manufacturing, quality control, quality assurance, or regulatory compliance, preferably in the medical device or pharmaceutical industry.</li>
</ul>
Responsibilities:
<ul>
<li>Review plant defect reports, customer complaints, failure investigations and audit findings to assess manufacturing related issues that may impact quality and recommend courses of corrective action.</li>
<li>Conduct manufacturing non conformances investigations, customer complaints, CAPA, failure investigations and audit findings.</li>
<li>Escalate manufacturing related issues that may impact quality and recommend courses of corrective action.</li>
<li>Participate in regulatory agencies audits.</li>
<li>Assist in the investigation of product non conformances and the gathering of information during regulatory inspections and field actions when required.</li>
<li>Approve or review product investigations reports.</li>
<li>Perform and report line defects trend analysis, cost of quality, and period quality summaries.</li>
<li>Participate in new product or technology transfers to assess the impact they may have on the quality and reliability of the product – assist in process validation protocol.</li>
<li>Follow-upon commitments to FDA and ISO observations for manufacturing related issues and report trends.</li>
<li>Perform quality system audits to determine compliance to FDA, ISO, and internal quality systems regulations and perform quality system surveys to evaluate the overall quality capability of a prospective or actual supplier or contractor.</li>
<li>Participate in the development, delivery, and administration of quality training programs including but not limited to GMP.</li>
<li>Be an active member in facility continuous improvement initiatives to assure continuation of quality measurement, planning, and improvement.</li>
<li>Provide leadership and guidance to a team of hourly or salary associates, including assigning tasks, setting clear goals, and monitoring performance, as required.</li>
<li>Facilitate training sessions to ensure team members are equipped with necessary skills and knowledge.</li>
<li>Develop individual team members through coaching and mentoring.</li>
</ul>

LL01-060325 Sr Quality Engineer

<h3>Job Description</h3>
Job Description
Validation &amp; Engineering Group, Inc. (V&amp;EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
<ul>
<li>CQV Scientist for Biotech Manufacturing Equipment</li>
</ul>
Qualifications:
<ul>
<li>Bachelor's Degree in Science or Engineering.</li>
<li>Minimum of 3 years of experience in direct pharmaceutical, medical device or preferably (biotechnology) industries.</li>
<li>Must be fully bilingual (English / Spanish) with excellent oral skills.</li>
<li>Experience in developing Systems Development Life Cycle (SDLC) documents such as VP, URS, DS, RA, IQ, OQ, PQ, TMX and so forth. Includes execution of protocols IOPQ, managing deviations, and reports generation.</li>
<li>Preferably experience in the Biotech industry.</li>
<li>Technical writing skills and investigations processes.</li>
<li>Available to work extended hours, possibility of weekends and holidays.</li>
</ul>

MF01-062725 CQV Scientist for Biotech Manufacturing Equipment

<h3>Job Description</h3>
Job DescriptionLocation: Tamarac, FL (Onsite)Schedule: Monday – Friday, 8:00 AM – 5:00 PM EST (occasional additional hours as needed)Travel: Up to 50% (Primarily domestic)Salary: $85,500.00Employment Type: Direct Hire OverviewWe are seeking a highly motivated Quality Engineer to join a leading manufacturing organization. In this role, you will play a pivotal role in ensuring the consistent quality of materials received from suppliers by auditing, developing, and maintaining strong relationships with key partners. You will also support internal quality efforts and help maintain the organization’s Quality Management System (QMS). Key Responsibilities
<ul>
<li>Collaborate with engineering and purchasing teams to support supplier development and onboarding.</li>
<li>Lead the PPAP (Production Part Approval Process) for new and existing products.</li>
<li>Audit and evaluate supplier facilities and processes, ensuring compliance and driving continuous improvement.</li>
<li>Manage Supplier Corrective Actions (SCAR) and validate implementation during audits.</li>
<li>Analyze process capability (Cp/Cpk) and provide training/support in LEAN and Six Sigma tools.</li>
<li>Maintain QMS documentation, audit schedules, supplier reports, and performance metrics.</li>
<li>Work closely with quality inspectors and engineering teams to ensure alignment on internal and external quality initiatives.</li>
</ul>
Must-Have Qualifications
<ul>
<li>Bachelor’s degree in Mechanical, Industrial, or related Engineering field.</li>
<li>Several years of engineering experience in a manufacturing environment.</li>
<li>Previous experience as a Quality Engineer.</li>
<li>Willingness to travel up to 50% for supplier visits and audits.</li>
<li>Hands-on experience with supplier auditing and corrective action processes.</li>
<li>Familiarity with quality core tools: process flow, PFMEA, control plan, etc.</li>
</ul>
Preferred Qualifications
<ul>
<li>Six Sigma Green Belt or Black Belt Certification</li>
<li>Kaizen event leadership experience</li>
<li>Lean Certification</li>
<li>Trained Auditor credentials</li>
<li>Experience with SAP and lean material management systems</li>
</ul>
Interview Process
<ul>
<li>Initial virtual interview with the hiring team</li>
<li>PI Assessment and follow-up virtual interview with hiring and HR representatives</li>
</ul>
Benefits Include
<ul>
<li>100% employer-paid medical coverage</li>
<li>Additional benefits including:
<ul>
<li>Dental</li>
<li>Vision</li>
<li>Life Insurance</li>
<li>401(k) match</li>
<li>Short-term and long-term disability plans</li>
</ul>
</li>
</ul>

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