Job Description
Job Description
Description
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The Process/Validation Engineer is responsible for providing engineering production support including:
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Implementing process and technology improvements
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Process and Cleaning Validation
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Equipment Qualification
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Collecting, monitoring, analyzing, troubleshooting, and reporting manufacturing data related to performance in the areas of quality, cost, and speed/service to market
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Investigating non-conformances, CAPAs, process performance drifts and implementing corrective and preventative actions
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Responsible for the initiation and follow-through of the change control processes.
Qualifications:
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Bachelor's degree in engineering, science or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 3-5 years of significant process engineering and/or operational experience in Medical Device or Pharmaceutical industry.
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Additional post-graduate education may contribute towards the desired years of experience.
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Experience with MS Office applications including Word, Excel & Outlook
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Demonstrated understanding and use of statistical methods in experiment design and data analysis
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Able to work independently and proactively in conjunction with all levels of the organization
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Excellent Technical writing skills and attention to fine detail.
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Understanding of AATB, FDA, ISO, ISPE, and other regulatory guidelines including understanding of the various regulations and guidelines such as FDA 21 CFR 11, 820 and 1270, ISO 11737, 13485 and 14644, and others, as required.
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Six Sigma, Value Stream Mapping, Lean Manufacturing, Design for Manufacturability, DOE
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Biological Products and aseptic processes
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Development of robust manufacturing processes, validation, and process monitoring
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Experience with root cause analysis methods
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Experience with applications including Minitab or other statistical software, Microsoft PowerPoint, Project, and Visio.
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Time management skills and follow-through skills with the ability to work on and manage multiple tasks with tight deadlines.
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Strategic thinking and planning.
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Excellent organizational skills.
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Excellent oral and written communication skills.
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Process and Cleaning Validation Experience
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Equipment Qualification (IOQ/PQ)
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Quality System Experience (Veeva, Trackwise, ComplianceWire)
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Medical Device or Pharmaceutical Experience Required. Preferred Medical Device with 3-5 Years
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Statistical Analysis (Minitab or JUMP)
Benefits:
Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.
Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.
Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.
Synectics is an equal opportunity employer.