Senior CQV Project Manager

PSC Biotech • Holly Springs, NC

8d

About The Position

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. The Experience With operations spanning the globe and featuring a multi -cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech®, it’s about more than just a job—it’s about your career and your future. Your Role PSC Biotech is seeking a Senior CQV Project Manager to lead and coordinate activities during a major facility shutdown. This role will oversee integrated planning and execution for construction, commissioning, operational readiness, small capital projects, and strategic maintenance initiatives. The ideal candidate will have strong experience in biopharmaceutical operations and a proven ability to manage complex, multi -workstream projects.

Requirements

• 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.
• At PSC Biotech, many of our projects are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.
• Must be authorized to work in the U.S
• No C2C at this time

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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level