Job: Senior Validation Engineer
Location: Kalamazoo, Michigan
Role: We are currently hiring a Senior Validation Engineer in Kalamazoo, Michigan to support our client"s (a leading global engineering consultancy) operations for a long-term contract for verification of a COVID vaccine manufacturing line. This is a great opportunity to join a well-established, global, business who are market leaders within their field. You will develop and implement engineering solutions to provide CSV/CQV support to clients that manufacture GMP products on a consistent basis in conjunction with industry best practices. This role is working for a Pharmaceutical company so you must have knowledge and experience with, manufacturing equipment, process equipment, HVAC, utilities, instrumentation, controls, and automation to support clients.
- 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
- Bachelor of Science in Chemical, Mechanical, Electrical or Computer Engineering
- 5-10 years of CSV experience in the life sciences industry
- Strong understanding of Good Manufacturing Practices (GMPs)
- Technical writing skills
- Proficient with Microsoft Office (Word, Excel, PowerPoint, etc.)
- Flexibility and willingness to travel and work at various client locations
- Ability to work well with diverse, multi-disciplined groups
- Effectively communicate with management and fellow project team members
- Negotiate or compromise with other project team members to achieve project goals
- Listen and respect fellow project team member"s ideas and opinions and work through conflicts or disagreements
- 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
Based on experience resource a qualified candidate may be assigned to 2nd shift. Must be open to working the 2nd shift.
Established in 1995, PTS Advance provides people and tools to companies that want to do more than just "fill a position". Our expertise includes attracted and retaining key talent, while managing assignments in a safe, compliant, and transparent manner. We are honest and transparent in the process because we put you first.
Interested in this position? Click Apply Now or reach out to Hannah Johnson at Hannah.Johnson@PTSadvance.com or (949)-268-4083.