PSC Biotech® Corporation · 2 weeks ago
Senior CQV Project Manager
Holly Springs, NC
Full-time
Hybrid
Senior Level, Lead/Staff
10+ years expPSC Biotech® Corporation provides essential services to the life sciences industry, ensuring compliance with regulatory standards. They are seeking a Senior CQV Project Manager to lead activities during a major facility shutdown, overseeing planning and execution for construction and operational readiness.
BiotechnologyConsultingLife ScienceProject ManagementQuality AssuranceRental
No H1B
Responsibilities
Coordinate all shutdown-related activities, including construction, CQV, operational readiness, and maintenance
Develop execution strategies, detailed schedules, and risk registers for shutdown projects
Facilitate scope definition for small capital projects and maintenance activities
Coordinate with project managers, schedulers, and manufacturing planners to align timelines and resource availability
Lead daily execution forums, cross-functional workshops, and governance meetings
Monitor schedule performance, manage risk, and escalate issues to maintain project objectives
Provide strategic guidance to optimize delivery and mitigate risks
Represent workstreams in governance forums and maintain stakeholder alignment
Qualification
Required
Bachelor's degree in Engineering (Mechanical, Chemical, or related field) or Life Sciences
10+ years experience in drug substance manufacturing or equivalent biopharma operations
Proven track record managing shutdowns from ramp-down through start-up
Expertise in construction and CQV projects within GMP environments
Familiarity with supporting functions such as Quality Control, Process Development, and Engineering
Proficiency in scheduling tools (Primavera P6 and MS Project)
Strong facilitation and communication skills
Knowledge of risk-based CQV approaches and GMP readiness criteria
Experience with risk registers and structured risk reviews
Willing and able to travel as needed for project assignments and client engagements
Must be authorized to work in the U.S
No C2C at this time
Benefits
Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
401(k) and 401(k) matching
PTO, Sick Time, and Paid Holidays
Education Assistance
Pet Insurance
Discounted rate at Anytime Fitness
Financial Perks and Discounts
Company
PSC Biotech® Corporation
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
John Clapham
CEO
Recent News
2025-12-18
2025-10-20
Company data provided by crunchbase