Senior Project Manager

Responsibilities

• Lead the development and execution of an integrated Verification and C&Q Program across the full project lifecycle
• Establish and implement project-specific verification strategies aligned with ASTM E2500 principles
• Manage overall C&Q scope, budget, schedule, resource planning, and project risks
• Serve as the primary point of contact for all C&Q-related matters with project leadership and stakeholders
• Ensure C&Q activities are integrated with engineering, construction, automation, validation, and quality plans
• Lead, mentor, and develop multidisciplinary C&Q teams
• Direct development, review, approval, and execution of verification plans, test cases, and commissioning protocols
• Ensure requirements traceability from design through testing and final system acceptance
• Monitor and report project progress, resource utilization, and budget performance
• Maintain compliance with GMP regulations and quality systems

Requirements

• Bachelor's Degree in Engineering, Life Sciences, or a related technical discipline
• 10–15+ years of experience in GMP-regulated pharmaceutical, biotechnology, or medical device projects
• Demonstrated experience leading Commissioning, Qualification, Verification, or Validation programs on large capital projects
• Experience delivering at least one major greenfield or brownfield GMP facility from design through startup
• Strong knowledge of ASTM E2500 verification methodology and risk-based qualification approaches
• Experience managing FAT, SAT, and system turnover activities
• Familiarity with GMP documentation, change controls, deviations, and CAPAs

Preferred Qualifications

• Advanced degree
• PMP certification or equivalent professional certification
• Experience with electronic validation systems such as Kneat or ValGenesis

About the Company

Syner-G is a strategic biopharma product development and delivery partner that accelerates breakthrough science and the delivery of life-enhancing therapies to patients.