Job DescriptionYour RoleWe 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
BenefitsOffering 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.
#LI-JL1
