Senior Project Manager

Responsibilities

• Provide strategic leadership for projects involving HVAC systems, facility infrastructure, commissioning, qualification, and validation.
• Lead C&Q execution strategy for manufacturing areas, utilities, cleanrooms, and support systems in GMP-regulated facilities.
• Manage commissioning, qualification, validation, startup, and turnover activities from construction to operational readiness.
• Coordinate daily activities of CQV engineers, contractors, vendors, and third-party service providers.
• Develop and manage project plans, schedules, budgets, and risk mitigation strategies.
• Oversee cleanroom implementation including airflow design, pressurization cascades, and contamination control.
• Review and approve commissioning and qualification documentation, including IQ/OQ/PQ protocols and turnover packages.
• Partner with Quality, Engineering, and Operations to ensure compliance with GMP requirements and regulatory expectations.
• Mentor and support project managers, CQV engineers, and validation specialists.

Requirements

• Bachelor's Degree in Engineering, Life Sciences, or a related technical field.
• 10–15 years of experience in GMP-regulated environments (biotech, pharma, or medical device).
• Extensive experience leading CQV, HVAC, and facility utility programs.
• Deep knowledge of cleanroom standards and contamination control principles.
• Experience with FAT, SAT, and integrated system testing.
• Familiarity with BMS, EMS, DCS, and SCADA systems.
• Proficiency with GMP documentation, change control, and CAPAs.

Preferred Qualifications

• Master's degree.
• PMP certification or equivalent project management credential.
• Experience with Kneat or other digital validation platforms.

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.