Senior CQV Engineer / Senior Validation Engineer 2
A leading provider of consulting and engineering services to the life sciences industry is seeking a Senior Commissioning, Qualification, and Validation (CQV) Engineer to support a high-impact project in Bloomington, Indiana. This role offers the opportunity to work on cutting-edge automated inspection systems and contribute to meaningful advancements in pharmaceutical manufacturing.
About the Role:
As a Senior CQV Engineer, you'll play a key role in executing commissioning and qualification activities for advanced automated equipment. You'll collaborate with cross-functional teams, maintain project documentation, and ensure compliance with regulatory and quality standards.
Key Responsibilities:
- Lead commissioning and qualification efforts for automated syringe inspection systems.
- Prepare, review, and execute validation protocols (URS, IQ, OQ, PQ).
- Track project progress, maintain documentation logs, and manage open items.
- Conduct risk and impact assessments in collaboration with project teams.
- Ensure alignment with project timelines and deliverables.
What We're Looking For:
- Willingness to work on-site in Bloomington, IN.
- Bachelor's degree in engineering or a related field (or equivalent experience).
- 5+ years of experience in CQV, particularly with automated inspection systems.
- Strong understanding of capital equipment implementation and validation processes.
- Familiarity with GMP standards and Good Documentation Practices.
- Proficiency in Microsoft Word (especially for technical documentation), Excel, and PowerPoint.
- Excellent communication and problem-solving skills.
- Experience with machine safety, Ethernet networking, and power system design is a plus.
Benefits Overview:
- Competitive salary with performance-based incentives
- Health, dental, and vision insurance
- Company-paid life and disability coverage
- Health Savings Account (HSA) and Flexible Spending Accounts (FSA)
- 401(k) with employer match
- Paid time off, holidays, and sick leave
- Tuition reimbursement and professional development support
- Parental leave and bereavement benefits
- Employee referral and recognition programs
- Team-building events and a collaborative work culture
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