Azzur Group
Elkhart, IN
Job Details
Contract
Full Job Description
ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients’ needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices. For more information, please visit our website at eliquent.com.
We are seeking an experienced CQV Engineer to support the commissioning, qualification, and validation of GMP systems in a regulated manufacturing environment. The ideal candidate will have hands-on experience with manufacturing processes, aseptic fill/finish operations, compressed air systems, and a thorough understanding of FDA regulatory requirements (cGMP, 21 CFR Part 11).
Key Responsibilities:
- Lead end-to-end Commissioning, Qualification, and Validation (CQV) activities for equipment and utility systems, ensuring compliance with site procedures, cGMP principles, and regulatory expectations.
- Provide expertise in VP, URS, system classification, and risk-based validation strategies to define appropriate qualification pathways for new and existing systems.
- Responsible for the qualification of systems such as pumps, batching tanks, transfer panels, HMIs, boiler, feedwater tank, compressed air, and computerized systems etc., ensuring traceability from design through to PQ.
- Execute and support Performance Qualification for processes such as computer system validation, bulk hold time validation, and cleaning/changeover activities.
- Develop and review technical documentation, including URS, risk assessments, validation protocols (IQ/OQ/PQ), summary reports, and the Equipment & Utility Validation Master Plan (VMP).
- Facilitate and contribute to FMEA risk assessments, worst-case product grouping evaluations, and cleaning validation strategies as part of the overall lifecycle approach.
- Deliver training and mentoring to the client employees on equipment validation, lifecycle concepts, risk-based validation, and documentation best practices.
- Ensure alignment with project timelines by coordinating validation deliverables across functions (QA, Engineering, Operations, compounding), while maintaining validation traceability and audit readiness.
Requirements
- Bachelor’s degree in Engineering (Mechanical, Chemical, Biomedical, or related discipline).
- 8-10 years of CQV experience in the pharmaceutical, biotech, or medical device industry.
- Strong knowledge of GMP environments, FDA regulations.
- Hands-on experience with:
- Aseptic manufacturing and filling lines
- Compressed air systems (ISO 8573-1 standards)
- Cleanroom environments and clean utility systems
- Proficient in validation documentation and electronic quality systems.
- Excellent communication, organization, and technical writing skills.
- Ability to manage multiple priorities and work both independently and within a team.
Preferred Qualifications:
- Experience with project-based environments (facility expansions).
- Familiarity with validation lifecycle approaches and computerized system validation (CSV).
- Lean/ Six Sigma certification is a plus.
Benefits
What We Offer:
- Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience.
- Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment.
- Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance.
Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.