Senior Pharmaceutical CQV Engineer
About The Position
Visium Resources has been asked to identify qualified candidates for this Pharmaceutical Senior CQV Engineer position. This position is a direct hire which is expected to be on-site in Boulder, CO. We are seeking a highly motivated Senior CQV Engineer to support commissioning, qualification, and validation activities for pharmaceutical and biotechnology manufacturing facilities. The successful candidate will lead and execute CQV deliverables associated with GMP-regulated process equipment, utilities, automation systems, cleanrooms, and manufacturing operations. This role requires hands-on technical expertise, strong project coordination skills, and a thorough understanding of FDA and cGMP compliance requirements. The Senior CQV 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 CQV, validation, or pharmaceutical 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.
- Excellent organizational and multitasking abilities
- Strong problem-solving and analytical skills
- Ability to manage multiple priorities and deadlines
- Comfortable working in both office and field environments
Nice To Haves
- Experience in biologics, sterile manufacturing, fill-finish, or aseptic processing environments.
- Previous consulting experience within life sciences industries preferred.
- Familiarity with: DeltaV, MES systems, SCADA platforms, Kneat or electronic validation systems
- PMP certification or equivalent project leadership experience is a plus.
- Strong client-facing communication and leadership skills.
Responsibilities
- Lead and execute CQV activities for pharmaceutical and biotech capital projects.
- Develop and execute: Commissioning plans, IQ/OQ/PQ protocols, Validation test scripts, Traceability matrices, Summary reports
- Support startup and qualification of: Process equipment, Clean utilities, HVAC systems, Manufacturing suites, Automation and control systems
- Coordinate field execution activities with engineering, construction, vendors, and operations teams.
- Perform system walkdowns and turnover package reviews.
- Support deviation investigations, CAPAs, and change control activities.
- Ensure all validation documentation complies with cGMP, FDA, ISPE, and GAMP guidelines.
- Participate in FAT/SAT execution and acceptance activities.
- Support project schedule development and milestone tracking.
- Collaborate with Quality Assurance and Manufacturing teams to support inspection readiness and successful system release.
- Mentor junior CQV engineers and validation specialists as needed.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
