CQV Engineer (Bloomington, IN)
About The Position
Pioneer GMP Consulting is seeking an experienced CQV Engineer to support the modification and restart of an aseptic vial-filling line for the introduction of a new product. The filling line and associated manufacturing space are currently in long-term hold and will be returned to GMP operation. The scope includes modifications required for the new product as well as qualification activities necessary to return the existing equipment, systems, and manufacturing area to service. The line includes a vial washer, depyrogenation tunnel, filling equipment, and isolator. This is a hands-on field role requiring direct protocol execution, discrepancy resolution, strong documentation, and close collaboration with project stakeholders.
Requirements
- At least five years of CQV, commissioning, qualification, or validation experience in GMP pharmaceutical or biotechnology manufacturing
- Direct experience supporting aseptic filling or sterile drug-product equipment
- Experience with filling lines, isolators, vial washers, depyrogenation tunnels, or comparable aseptic equipment
- Hands-on experience developing and executing IOQ and PQ protocols
- Experience testing equipment functions, alarms, interlocks, operating sequences, and automation
- Experience documenting and resolving protocol discrepancies and deviations
- Strong understanding of cGMP requirements and validation-lifecycle principles
- Strong technical writing and qualification-report experience
- Ability to perform hands-on field execution and work independently
- Ability to work 100% onsite in Bloomington throughout the engagement
Nice To Haves
- Experience restarting or recommissioning an aseptic filling line
- Experience returning equipment or manufacturing areas to service following a long-term hold
- Experience supporting new-product introduction on existing filling equipment
- Experience with isolator qualification and integrated line testing
- Experience supporting sterile facility startups, expansions, or remediation projects
- Prior CQV consulting experience
Responsibilities
- Support commissioning and qualification of an aseptic vial-filling line and isolator
- Support qualification of the vial washer, depyrogenation tunnel, filling equipment, and associated systems
- Develop, review, and execute IOQ and PQ protocols
- Perform field walkdowns and verify system installation, configuration, instrumentation, and readiness
- Test equipment functions, operating sequences, alarms, interlocks, recipes, and automation interfaces
- Support qualification activities associated with new-product modifications
- Evaluate existing systems following long-term hold and support their return to GMP service
- Document and resolve protocol discrepancies, deviations, punch-list items, and documentation gaps
- Prepare qualification reports and supporting turnover documentation
- Coordinate testing with Engineering, Automation, Operations, Quality, Validation, vendors, and equipment suppliers
- Communicate execution progress, technical findings, risks, and readiness concerns
- Support operational-readiness and manufacturing-readiness activities as needed
- Represent Pioneer with professionalism, technical credibility, and accountability
Benefits
- Competitive consulting rates commensurate with experience.
- Travel reimbursement and related expenses may apply based on engagement requirements.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
