What are the responsibilities and job description for the Senior CQV Project Manager position at PSC Biotech® Corporation?
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.
Offering a full suite of benefits, PSC Biotech⢠is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.
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.
- 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.
- 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
Offering a full suite of benefits, PSC Biotech⢠is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
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
PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.