Validation Engineer
The Judge Group Inc.

Job Info

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Location: Kalamazoo, MI
Salary: 65
Description: Our client is currently seeking a Validation Engineer

Qualifications:

This is for Verification of a COVID vaccine manufacturing line. Experience with writing and executing CQV documents for Freeze Dryers is preferred.

Minimum Qualifications:

The ideal candidate for this position will possess the following:

• BS Chemical, Mechanical, Electrical or Computer Engineering or equivalent

• 5-10 years of CSV experience in the life sciences industry

• Understanding of Good Manufacturing Practices (GMPs)

• Technical writing skills

• Proficient with Microsoft Office - Word, Excel, PowerPoint, Project

• Flexibility and willingness to travel and work at various clients' locations

• Ability to work well with diverse, multi-disciplined groups

• Ability to effectively communicate with management and fellow project team members

• Ability to negotiate/compromise with other project team members to achieve project goals

• Ability to listen and respect fellow project team member's ideas and opinions and work through conflicts or disagreements

Preferred Qualifications:

• Experience with Aseptic Fill/Finish lines

• Experience with Freeze Dryers

• Experience with qualifying SCADA systems

• Experience with qualifying Delta V systems

• Experience with qualifying BAS and BMS system

Responsibilities:

Technical/Functional Responsibilities: Provide CSV/CQV support to clients that manufacture GMP products on a consistent basis in conjunction with industry best practices:

• Develop CSV/CQV planning documents to manage CQV projects

• Generate and execute CSV/CQV protocols (IQ/OQ/PQ) using Good Documentation Practices (GDPs)

• Investigate and resolve protocol exceptions or discrepancies

• Develop technical reports and CSV/CQV summary reports

• Startup equipment and systems in a safe and effective manner

• Develop GxP computer validation and CFR 21 Part 11 related documentation such as assessments, plans, URS, FRS and summary reports

• Perform risk assessments and impact assessments

• Apply engineering knowledge of, and experience with, manufacturing equipment, process equipment, HVAC, utilities, instrumentation, controls, and automation to support clients

Contact: kzywalewski@judge.com

This job and many more are available through The Judge Group. Find us on the web at www.judge.com

This job has expired.