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<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
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 DescriptionThe Quality Engineer is responsible for maintaining and improving quality processes throughout production. This includes managing corrective actions, investigating complaints, conducting quality inspections, and ensuring training compliance. The role also involves working closely with process engineers to address root causes of quality issues and ensuring proper documentation is maintained for internal and external use. Pay Scale $30,000 to $80,000. Benefits Include Medical, Dental and Vision. Responsibilities:
<ul>
<li>Identify and implement internal corrective actions to address quality concerns.</li>
<li>Collaborate with process engineers to determine root causes of defects or complaints.</li>
<li>Document and maintain records of corrective actions and submit required reports to customers and internal stakeholders.</li>
<li>Perform quality checks at the end of every process to ensure compliance with company standards.</li>
<li>Utilize testing tools and equipment, including microscopes, solder testing equipment, and other specialized instruments, for product evaluation.</li>
<li>Follow established procedures (14/15 procedures) to ensure consistent quality testing.</li>
<li>Investigate product complaints to identify root causes.</li>
<li>Work closely with process engineers to develop and implement corrective measures.</li>
<li>Document and communicate investigation findings and resolutions to stakeholders.</li>
<li>Audit staff training based on training schedules and documented procedures.</li>
<li>Verify that employees have completed training and are following approved processes.</li>
<li>Address discrepancies, provide additional training as needed, and reschedule training sessions to ensure compliance.</li>
<li>Regularly inspect and calibrate testing tools to maintain their accuracy and reliability.</li>
<li>Monitor the use of tools and equipment during quality checks to ensure compliance with standards.</li>
<li>Suggest Process Improvement</li>
<li>Maintain detailed records of quality inspections, corrective actions, and training audits.</li>
<li>Prepare reports on quality performance metrics, process improvements, and training compliance.</li>
<li>Ensure all documentation complies with customer and internal requirements.</li>
</ul>
 Qualifications:
<ul>
<li>Bachelor's degree in Engineering, Quality Assurance, or a related field (or equivalent experience).</li>
<li>Previous experience in a quality engineering role, preferably in a manufacturing or production environment.</li>
<li>Familiarity with quality management systems and industry standards.</li>
<li>Strong knowledge of quality assurance standards, tools, and techniques.</li>
<li>Experience with root cause analysis and corrective action implementation.</li>
<li>Proficiency in using inspection equipment such as microscopes and solder testing tools.</li>
<li>Strong attention to detail and problem-solving abilities.</li>
<li>Effective communication and collaboration skills.</li>
<li>Organizational and documentation skills.</li>
</ul>
 &nbsp;
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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>Cleaning Validation Scientist </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 biotechnology industries.</li>
<li>Solid experience generating Cleaning Validation Protocols for Manufacturing Equipment, according to the strategy depicted in the Cleaning Validation Master Plan</li>
<li>Advanced validation knowledge (cleaning validation, equipment qualification, sterilization).</li>
<li> Applies extensive technical validation expertise and has full knowledge of other related disciplines.</li>
<li>Must be fully bilingual (English / Spanish) with excellent oral skills.</li>
<li>Must be proficient using MS Windows and Microsoft Office applications.</li>
<li>Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.</li>
<li>Technical Writing skills and investigations processes.</li>
<li>Available to work extended hours, possibility of weekends and holidays.</li>
</ul>

MF01-070125 Cleaning Validation Scientist

<h3>Job Description</h3>
Job DescriptionTITLE: SMERF Engineer Senior LOCATION: Washington DC MINIMUM EDUCATION: Bachelors degree in IT, related field, or equivalent experience. REQUIRED EXPERIENCE: 7+ years INTERVIEWS: In person Job Description: The Client looking for the 11-15 years of experience. Provides assessments of technical and operational practices based on leading industry standards specific to the requested technology. Complete Description: The Contractor shall provide a RF Engineer with at least five years of experience working at a Public Safety Answering Point (PSAP). The RF Engineering Consultant will be responsible for working with LMR radio system, software, and programs. In addition, the RF Engineering Consultant will also be responsible for designing / testing radio code plugs validating radio and system performance and evaluating new communication devices. The RF Engineering Consultant will perform technical work in the field of Land Mobile Radio (LMR) and wireless communications system engineering, design, and implementation. The consultant will be responsible for program review, compliance with licensing regulations, requirements gathering, design review, change management, and final acceptance of systems. Duties will include RoIP system engineering and radio code plug design / programming. Furthermore, the consultant will conduct short and long-term planning to meet communications requirements. The consultant will also be responsible for performing hardware / software analysis to provide comparative data of performance characteristics and suitability within the existing systems environment. Skills: SME in complex enterprise level projects. Required 11 Years Masters degree in IT or related field or equivalent experience. Required Experience working in a PSAP. Required 5 Years interoperable radio experience. Required 3 Years Land Mobile Radio experience. Required 3 Years Radio network coverage and interference analysis experience. Required 3 Years Experience with RF engineering tools including Wizard and drive test tools. Required 3 Years Experience in developing fleetmaps, code plugs, and programming radios for public safety. Required 3 Years Experience managing Motorola User Configuration Manager. Required 3 Years Experience in troubleshooting WS systems, including but not limited to cell, microwave, LMR, UHF, etc. Required 3 Years Experience with public safety infrastructure. Required 3 Years Experience with P25 radio network. Required 3 Years Experience and knowledge of public safety communications and interoperability. Required 3 Years Experience and knowledge with LTE and WIMax Standard practices. Required 3 Years Experience and knowledge of PSAP operations. Required 3 Years Experience and knowledge of wireless communications - combination of theory and practice. Required 3 Years 
Flexible work from home options available.

SME RF Engineer Senior

<h3>Job Description</h3>
Job Description
Job Description The highly experienced quality professional who works under supervision, learns quickly, and brings ideas and passion to their daily responsibilities and executes work to completion with excellence in a timely manner. Skill/Experience Requirements: 8+ years of QA experience Experience working with CI tools (Jenkins, TeamCity, GitLab etc.) Experience with QA processes and deliverables in an Agile/Scrum environment Proficient in defect tracking and analyzing root cause utilizing tools (Jira , Rally etc.) Strong understanding of automation and performance concepts and approaches. Experience working with or on remote teams Understand and utilize risk-based testing technique Experience in test environment and test data management Strong communication, leadership and collaboration skills, to challenge the norm Specialization/Role Requirements for Automation 5+ years of experience writing Selenium tests in Java or Javascript using ( Web Driver , Web Driver IO, Marathon , Appium etc.) 5+ years of experience with test runners (Junit, TestNG, Mocha, Jasmine) 5+ years of experience with CI tools (Jenkins, TeamCity, GitLab) 2+ years of experience with Selenium Grid 3+ years of working in an Agile/Scrum methodology 2+ years of using Jira for defect tracking Key Responsibilities Effectively work in a fast paced environment utilizing the Agile methodology Develop and maintain functional automation test scripts utilizing modular frameworks and best practices Execute test scripts to validate correct functionality of application Use SQL for back-end database validation Perform various types of testing including smoke, white box, black box, integration, end-to-end, regression, and system testing as needed Participate in requirement &amp; design review sessions; evaluate requirements &amp; design docs from a quality test automation standpoint Manage test coverage based on risk analysis Document defects and evaluate priority of defect based on overall application functionality Coordinate test script reviews with stakeholders as appropriate. Adhere to requirement review, defect writing &amp; test script writing guidelines Ensure completion of all deliverables within schedule, budget and quality constraints. Participate in Root Cause Analysis sessions Ensure that projects follow prescribed software development life cycle standards. Develop and maintain good relationships with project team. Multi-task to meet assignment deadlines Accurately estimate work assignments Show assertiveness Identify obstacles and roadblocks; and offer suggestions to work around obstacles Help drive and improve QA process within the team you are assigned Note to Vendors Top 3 skills: Resource should have cross-functional QA expertise - automated frontend testing, test plan lifecycle, test data management, etc. Also looking for a resource with prior MAWM experience. Soft Skills Needed: communication, working with 3rd parties and vendors/offshore, collaboration, experience in large enterprise systems as well. Project person will be supporting: working on the warehouse management system project. This Lead QE will need to ensure Manhattan Project is successful Team details: mostly overseeing a team of contractors. Not a direct report role but will have supervision Work Location (in office, hybrid, remote): strongly prefers in office at BTC would be the smoothest. 2nd option would be open to hub city, but they would need to be willing to relocate to cinci Is travel required: Possibly Required Working Hours: EST time zone Interview process and when will it start: 2 round interview process Prescreening Details: automated, 5 questions and a game When do you want this person to start: Beginning/mid-April

Quality Engineer - Data Level 3

<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 Description
Workspireis closely partnered with a 100% Employee-Owned and growing Design/Build organization specializing across Planning, Engineering, Architecture, Construction, and Utilities. We've placed over 10 people within this organization and are true brand champions based on this client's unmatched focus on internal employee engagement and progressive, people-first policies.
As a full spectrum Design/Build organization, they oversee a large variety of project types across Commercial, Residential, Municipal, Industrial, Land Development, Water, and Agricultural.
If you're interested in becoming an owner in a people-first organization with exciting project work and growing to $100M+ in revenue, please apply!
 
They are seeking a skilled Civil Engineer to join the Water-focused Agriculture department. This person will have a deep understanding of hydraulics and a passion for sustainable water solutions in Agriculture. This role focuses on design, project budgeting, client relationship management, quality control, site visits, and overall project management. This position is primarily office-based, with occasional field visits as needed.
 
Key Responsibilities:
<ul>
<li>Design, analyze, and oversee hydraulic systems for agricultural projects, including manure management, lagoon systems, digesters, and drainage.</li>
<li>Collaborate with multidisciplinary teams to support methane digester design, permitting, and construction efforts.</li>
<li>Perform hydraulic modeling, pump and pipe sizing, and flow analysis to optimize system efficiency and performance.</li>
<li>Conduct site assessments and generate civil site plans, grading and drainage plans, and utility layouts.</li>
<li>Interface with clients, permitting agencies, and internal stakeholders to ensure designs meet regulatory requirements.</li>
<li>Prepare construction documents, technical reports, and specifications.</li>
<li>Support field construction efforts by providing engineering oversight and responding to RFIs and design adjustments.</li>
<li>Conduct engineering analyses and prepare technical reports.</li>
<li>Ensure compliance with environmental regulations and industry standards.</li>
<li>Utilize AutoCAD (Civil 3D preferred) to develop engineering designs and plans.</li>
<li>Collaborate with multidisciplinary teams to drive project success.</li>
</ul>
 
Qualifications:
<ul>
<li>Bachelors degree in Civil Engineering or related field; Masters degree preferred.</li>
<li>3+ years of experience in water-focused civil or environmental engineering, ideally with agricultural systems.</li>
<li>Strong knowledge of hydraulics, fluid mechanics, and agricultural water infrastructure.</li>
<li>Experience with methane digesters, anaerobic systems, or nutrient recovery systems is highly desirable.</li>
<li>Proficiency in AutoCAD Civil 3D, HEC-RAS, EPANET, or other modeling tools.</li>
<li>Familiarity with state and federal water/environmental regulations related to agriculture.</li>
<li>PE license preferred (or ability to obtain within 12 months).</li>
<li>Proficiency in AutoCAD (2009 or newer; Civil 3D preferred).</li>
<li>Strong skills in Microsoft Office (Word, Excel, etc.).</li>
<li>Excellent written and verbal communication skills.</li>
</ul>
 
Benefits:
<ul>
<li>100% Paid Healthcare Premium</li>
<li>401(k) with Company Contribution</li>
<li>Generous PTO</li>
<li>Paid Holidays</li>
<li>PerformanceBonuses</li>
</ul>
 
If youre a Civil Engineer passionate about agricultural engineering, wastewater processing, and sustainable solutions, wed love to hear from you!
 
We are an equal opportunity employer and value diversity at all levels of the organization. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We are committed to creating an inclusive environment for all employees.
 
#LI-WS

Water/Hydraulic 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>Validation Specialist</li>
</ul>
Qualifications:
<ul>
<li>Bachelor's Degree in Engineering.</li>
<li>Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.</li>
<li>Experience in direct process / manufacturing areas.</li>
<li>Must be fully bilingual (English / Spanish) with excellent oral skills.</li>
<li>Must be proficient using MS Windows and Microsoft Office applications.</li>
<li>Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.</li>
<li>Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.</li>
<li>SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) &amp; Site Acceptance Test (SAT).</li>
<li>Strong knowledge in medical devices equipment preferred.</li>
<li>Technical Writing skills and investigations processes.</li>
<li>Available to work extended hours, possibility of weekends and holidays.</li>
</ul>

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