Senior Pharmaceutical CQV Engineer
On-siteBoulder, Colorado, United States
Job Summary
Lead and execute commissioning, IQ/OQ/PQ protocols, and validation test scripts for pharmaceutical and biotech capital projects. Coordinate field execution with engineering, construction, vendors, and operations teams while performing system walkdowns and turnover package reviews. Support startup of process equipment, clean utilities, HVAC systems, and automation controls. Ensure all documentation complies with cGMP, FDA, ISPE, and GAMP guidelines. Manage project schedules, milestone tracking, and deviation investigations. Collaborate with QA and Manufacturing to support inspection readiness and system release. Mentor junior engineers and validation specialists.
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
- Strong knowledge of FDA validation requirements
- Strong knowledge of ISPE Baseline Guides
- Strong knowledge of GAMP 5 principles
- Experience executing commissioning and qualification for Process equipment
- Experience executing commissioning and qualification for Utilities
- Experience executing commissioning and qualification for HVAC systems
- Experience executing commissioning and qualification for Cleanrooms
- Experience executing commissioning and qualification for Automation systems
- Experience authoring and reviewing validation lifecycle documentation
- Strong technical writing and documentation skills
- Ability to work independently within fast-paced project environments
- Ability to travel to client sites as required
Desired Qualifications
- Experience in biologics, sterile manufacturing, fill-finish, or aseptic processing environments
- Previous consulting experience within life sciences industries
- Familiarity with DeltaV
- Familiarity with MES systems
- Familiarity with SCADA platforms
- Familiarity with Kneat or electronic validation systems
- PMP certification or equivalent project leadership experience
- Strong client-facing communication and leadership skills
- 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
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