CQV Project Manager

About the Company

PSC Biotech® is a global team of skilled professionals with operations spanning North America, Europe, Asia, and the Middle East. We are passionate about bringing together diverse talent to help clients achieve success through robust validation strategies and industry best practices. Our culture values inspiration, professional growth, and collaboration, offering tools and opportunities to develop the next generation of industry leaders.

About the 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 validation strategies while adhering to regulatory requirements and industry best practices. This role involves delivering comprehensive support to clients across all phases of the CQV lifecycle, including manufacturing facility expansions and capital project initiatives.

Key responsibilities include providing expert leadership in project planning, strategic development, and execution for facility build-outs, expansions, upgrades, and capacity increases while maintaining compliance and product quality.

Responsibilities

• Manage end-to-end CQV activities for capital projects, including URS development, FAT/SAT execution, and validation documentation for GMP-compliant pharmaceutical production environments.
• Support manufacturing facility expansion projects, such as new production areas, cleanroom expansions, utility upgrades, or facility modifications.
• Oversee the full CQV lifecycle, from project planning and scheduling to budget management, risk mitigation, and stakeholder communication.
• Coordinate with vendors and contractors to ensure project success.
• Apply a risk-based approach to CQV activities while ensuring compliance with industry regulations and guidelines.
• Demonstrate strong problem-solving and analytical skills to maintain quality and compliance.

Requirements

• Bachelor's degree in a related engineering discipline.
• 5+ years of experience managing CQV activities for capital projects.
• Demonstrated experience supporting manufacturing facility expansion projects.
• Expertise in project planning, initiation, execution, and closure.
• Strong attention to detail and commitment to quality and compliance.
• Must be authorized to work in the U.S. (No C2C at this time).

Benefits

• Medical, Dental, and Vision: PSC pays 100% of qualifying employee medical premiums and 50% for qualifying dependents.
• Insurance options: Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability, and more.
• 401(k) with company matching.
• Paid Time Off (PTO), Sick Time, and Paid Holidays.
• Education Assistance.
• Pet Insurance.
• Discounted rate at Anytime Fitness.
• Financial Perks and Discounts.

Pay

The salary bracket for this role is $115,000 - $140,000 annually, with adjustments based on qualifications, skills, and professional experience.