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Senior Validation Engineer
Kenosha
, Wisconsin $90,480/Year Direct Hire
Hybrid
Senior Validation Engineer
Kenosha, WI
Competitive Pay and Benefits
The Senior Validation Engineer will support Commissioning, Qualification, and Validation (CQV) activities within the Pharmaceutical and Life Sciences industries. This role will be instrumental in ensuring projects meet safety, compliance, and quality standards. The ideal candidate will bring expertise in GMP environments and demonstrate strong communication, technical, and organizational skills.
Senior Validation Engineer Responsibilities:
Senior Validation Engineer Requirements:
Kenosha, WI
Competitive Pay and Benefits
The Senior Validation Engineer will support Commissioning, Qualification, and Validation (CQV) activities within the Pharmaceutical and Life Sciences industries. This role will be instrumental in ensuring projects meet safety, compliance, and quality standards. The ideal candidate will bring expertise in GMP environments and demonstrate strong communication, technical, and organizational skills.
Senior Validation Engineer Responsibilities:
- Perform Commissioning, Qualification, and Validation (CQV) tasks with a strong focus on safety
- Deliver C&Q activities on schedule and in alignment with project plans
- Track and report on CQV progress and milestones
- Generate, review, and revise CQV documentation including SOPs, validation protocols, and master plans
- Assist with equipment design qualifications and regulatory compliance documentation
- Ensure adherence to industry standards and GMP regulations
- Plan for commissioning spares, consumables, and necessary resources
- Allocate project resources to support efficient execution
- Coordinate internal teams and logistics during CQV execution phases
- Execute and support FATs, SATs, design reviews, equipment shakedown, and IQ/OQ/PQ testing
- Liaise with contractors and vendors to coordinate validation and testing activities
Senior Validation Engineer Requirements:
- Bachelor’s degree in Engineering, Chemistry, Life Sciences, or a related field (or equivalent professional experience)
- Minimum of 2 years of experience in the Pharmaceutical or Life Sciences industry
- Familiarity with GMP-compliant environments and regulatory standards
- Excellent written and verbal communication skills
- Strong analytical and problem-solving capabilities
- Customer-focused approach with flexibility to travel domestically (and potentially internationally)
- Prioritizes and manages tasks to ensure project success
- Proactively removes obstacles and drives completion
- Tailors technical communication to suit a variety of audiences
- Builds relationships across functions to foster collaboration
- Demonstrates integrity and a commitment to continuous improvement
- Seeks opportunities to grow professionally and support team development
