Pharmaceutical C&Q Engineer - Packaging
About The Position
Visium Resources has been asked to identify qualified candidates for this Pharmaceutical C&Q Engineer position focused on packaging. This position is a direct hire which is expected to be on-site in New Albany, OH. This position is for the second shift. We are seeking a highly motivated C&Q Engineer to support working on packaging equipment & device assembly equipment C&Q in our customers manufacturing facilities. This role requires hands-on technical expertise, strong project coordination skills, and a thorough understanding of FDA and cGMP compliance requirements. The C&Q Engineer will work cross-functionally with Engineering, Quality, Manufacturing, Automation, and external vendors to ensure successful project execution and operational readiness within fast-paced life sciences environments.
Requirements
- Bachelor's degree in Engineering, Life Sciences, Biotechnology, or related technical discipline.
- 5-10+ years of C&Q engineering experience within GMP-regulated environments.
- Strong knowledge of: cGMP regulations
- FDA validation requirements
- ISPE Baseline Guides
- GAMP 5 principles
- Experience executing commissioning and qualification for: Process equipment
- Utilities
- HVAC systems
- Cleanrooms
- Automation systems
- Experience authoring and reviewing validation lifecycle documentation.
- Strong technical writing and documentation skills.
- Ability to work independently within fast-paced project environments.
- Strong client-facing communication and leadership skills.
Nice To Haves
- device assembly C&Q experience is not required, but an asset
- environmental rooms (i.e. incubators, cold rooms, freezers, etc..) C&Q experience is not required, but an asset
- Kneat paperless validation experience is not required, but an asset
Responsibilities
- Lead and execute C&Q activities for pharmaceutical and biotech capital projects.
- Prior packaging equipment C&Q experience is required.
- Ability to write & execute C&Q documents
- Close deviations, troubleshoot, communicate with customer, vendors, etc…
- Track issues, close issues
Benefits
- direct hire
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What This Job Offers
Job Type
Full-time
Career Level
Senior
