CQV Engineer

• Experience: 5+ years executing CQV activities for facilities, including Functional Verification (FV), Functional Qualification (FQ), smoke studies, and Environmental Monitoring Performance Qualification (EM-PQ).
• Key Skills: Walkthroughs, layouts, and controlled environment assessments.

• Experience: 5+ years in commissioning and qualification of utilities, including WFI loops, clean steam, process air, etc.
• Core Activities: CU-PQ, CQT, loop checks, calibrations, and ECN execution.

• Experience: 5+ years in CQV of new equipment such as ATF, RTF, chromatography skids, UF/DF systems, and perfusion tanks.
• Responsibilities: FAT/SAT execution, SIP-PQ, commissioning, and qualification protocol development.

• Experience: 5+ years supporting modifications of existing equipment, including tie-ins, tanks, valves, and filtration systems.
• Activities: QSR generation, SIP-PQ, impact assessments, and documentation reviews.

• Hands-on experience with Kneat, LIMS, CDOCS, and Maximo.
• Strong knowledge of GDP, GMP, and 21 CFR Part 11 regulations.
• Experience with risk-based validation and a lifecycle approach to CQV.
• Must be available to work 50 hours per week on-site at Amgen Juncos.

• Plan, execute, and document Commissioning, Qualification, and Validation (CQV) activities for facilities, utilities, and equipment.
• Develop and execute risk-based validation strategies, master plans, protocols, and technical assessments.
• Lead and support FAT/SAT/IQ/OQ/PQ, CU-PQ, EM-PQ, CQT, loop checks, calibrations, and post-modification validations.
• Collaborate with cross-functional teams in Engineering, Operations, Quality, and Supply Chain to ensure operational readiness and compliance.
• Ensure adherence to GMP, GDP, and regulatory requirements including FDA Guidelines, EU Annex 1, ASTM E2500, and ISO 14644.
• Support internal and external audits, responding to regulatory findings as needed.
• Maintain accurate and timely documentation across all systems (Kneat, LIMS, CDOCS, Maximo).

• Ph.D. in Engineering → Minimum 2 years CQV experience in regulated environments.
• Master’s Degree in Engineering → Minimum 4 years CQV experience.
• Bachelor’s Degree in Engineering → Minimum 5 years CQV experience (required for all specialties).

• Strong technical writing and reporting skills.
• Demonstrated ability to manage multiple CQV projects simultaneously.
• Experience working in biotech or pharmaceutical manufacturing environments.
• Familiarity with risk assessments, impact analysis, and change control processes.

Weil Group