CQV Project Manager

Job Opportunity at PSC Biotech

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-versed 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 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.