The Role
Lead end-to-end commissioning, qualification, and validation projects for pharmaceutical manufacturing facility expansions, upgrades, and capacity increases. Manage project planning, scheduling, budgets, risks, stakeholders, vendors, and contractors while ensuring GMP compliance, product quality, regulatory adherence, and complete validation documentation across the CQV lifecycle.
Summary Generated by Built In
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
We are seeking a highly skilled and motivated CQV Project Manager to join our team. You will work closely with cross-functional teams to support the development and implementation of robust validation strategies, while adhering to regulatory requirements and industry best practices.
Our CQV Project Managers deliver comprehensive support to clients across all phases of the CQV lifecycle, including manufacturing facility expansion and capital project initiatives. This includes providing expert leadership in project planning, strategic development, and execution to support facility build‑outs, expansions, upgrades, and capacity increases while maintaining compliance and product quality.
Requirements
- Bachelor's degree in related engineering discipline.
- 5+ years of experience managing end-to-end CQV activities for capital projects, including URS development, FAT/SAT execution, and validation documentation for GMP-compliant pharmaceutical production environments
- Demonstrated experience supporting manufacturing facility expansion projects, including new production areas, cleanroom expansions, utility upgrades, or facility modifications.
- Experienced managing full CQV lifecycle projects. Highly skilled in project planning and scheduling, budget management, risk mitigation, stakeholder communication, and vendor/contractor coordination.
- Well-veresed in CQV risk based approach.
- Expertise in industry regulations, requirements, and guidelines.
- Proven success in project planning, initiation, execution, and closure.
- Strong attention to detail and commitment to quality and compliance.
- Strong problem solving and analytical skills.
- Must be authorized to work in the US.
- No C2C at this time
Benefits
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
The salary bracket for this role is set between $115,000 - $140,000 annually. The salary offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.
Equal Opportunity Employment Statement
PSC Biotech 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.
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Skills Required
- Bachelor's degree in a related engineering discipline
- 5+ years managing end-to-end CQV activities for capital projects
- Experience with URS development, FAT/SAT execution, and validation documentation
- Experience in GMP-compliant pharmaceutical production environments
- Experience supporting manufacturing facility expansion projects, including production areas, cleanrooms, utilities, or facility modifications
- Experience managing full CQV lifecycle projects
- Expertise in project planning, scheduling, budget management, risk mitigation, stakeholder communication, and vendor/contractor coordination
- Knowledge of risk-based CQV approaches
- Expertise in industry regulations, requirements, and guidelines
- Demonstrated success in project planning, initiation, execution, and closure
- Strong attention to detail and commitment to quality and compliance
- Strong problem-solving and analytical skills
- Authorization to work in the United States
- No C2C arrangements
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The Company
What We Do
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support. To date, PSC Biotech Corporation now serves 1000 clients in more than 35 countries worldwide through professional services consulting, cloud-based software solutions, pharmaceuticals contract manufacturing, life science investment consulting, and metrology services. PSC Biotech Corporation has six unique divisions within the parent company – each representing one of our areas of expertise: PSC Biotech, PSC Software, BioTechnique™, PSC Partners, PSC Metrology and PSC Investments. Additionally, PSC Asia and PSC Biotech Ltd represent PSC Biotech Corporation in Asia and Europe, respectively. Together, these divisions enable us to meet the ever-changing needs of our clients with a commitment to excellence and superior quality.
