Description

You serve as the primary Commissioning & Verification (C&V) Subject Matter Expert for a dedicated project workstream. You define commissioning and verification requirements, including risk assessments, testing strategies, and acceptance criteria.

Responsibilities

• Review technical specifications, drawings, and vendor design submittals (FAT, SAT, IQ/OQ) with a focus on GMP-critical aspects.
• Lead the development and execution of verification documentation in accordance with cGMP requirements and quality standards.
• Collaborate with Engineering Project Management, Automation, Maintenance, Operations, and Quality stakeholders to establish priorities.
• Partner with other workstream leads to ensure an integrated verification strategy for equipment and systems.
• Assist the C&V Lead with status reports, cost estimates, budgets, and schedule analysis.

Required Skills

• 4+ years of technical experience in a pharmaceutical or FDA-regulated manufacturing environment.
• Strong working knowledge of cGMP and facility/equipment validation requirements.
• Experience with testing automated manufacturing equipment and systems.
• Proficiency in SAT, IQ/OQ, and vendor design submittal reviews.
• Understanding of risk-based approaches to commissioning and qualification following ASTM E2500 standards.
• Ability to manage change control implementation within a matrix organization.
• Professional written and oral communication skills for technical documentation and presentations.
• Bachelor of Science in an engineering or life science technical field.

Preferred Skills

• Experience with Engineering Project Management, Automation, Maintenance, and Operations workflows.

Key Skills

Education

Bachelor's degree