Position Summary
Pharmaceutical Senior CQV Engineer position is a direct hire which is expected to be on-site in Boulder, CO.
Summary
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.
Key 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.
Required Qualifications
- 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.
Preferred Qualifications
- 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.
Additional Skills & Competencies
- 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
Ability to travel to client sites as required
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