CQV Project Lead

PSC Biotech • Richmond, VA

5d • $60 - $80 • Onsite

About The Position

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.
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.

Requirements

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, or a related technical discipline.
• 8+ years of experience in CQV, Validation, Engineering, or Project Management within the pharmaceutical or biotechnology industry.
• Demonstrated experience supporting advanced biologics manufacturing facilities and operations.
• Proven experience leading CQV projects and managing cross-functional teams in GMP-regulated environments.
• Strong experience developing and managing project schedules, resource forecasts, and staffing plans.
• Experience overseeing commissioning, qualification, and validation activities, including IQ/OQ/PQ execution and validation documentation.
• Working knowledge of cGMP regulations, FDA requirements, and industry best practices related to CQV execution.
• Excellent organizational, leadership, communication, and stakeholder management skills.
• Experience managing multiple project priorities, vendors, and contractors in a fast-paced project environment.
• Proficiency with project scheduling and planning tools such as Microsoft Project, Smartsheet, Primavera P6, or equivalent.

Responsibilities

• Lead and oversee C&Q activities from project initiation through closeout, ensuring alignment with project objectives, timelines, and regulatory requirements.
• Ensure successful mobilization, onboarding, and coordination of C&Q teams to support project execution.
• Develop, maintain, and manage project schedules, resource forecasts, and staffing plans to support successful project delivery.
• Provide oversight of commissioning, qualification, and validation activities, ensuring deliverables are completed in accordance with approved plans and quality standards.
• Coordinate C&Q activities across Engineering, Manufacturing, Quality Assurance, Validation, and Operations organizations.
• Monitor project progress, identify risks and issues, and implement mitigation strategies to maintain schedule and budget commitments.
• Manage external vendors, contractors, and consulting partners supporting C&Q execution.
• Ensure documentation, protocols, reports, and turnover packages meet GMP and regulatory requirements.
• Prepare and communicate project status updates, resource requirements, risks, and milestones to clients and senior stakeholders.
• Support continuous improvement initiatives and promote best practices in C&Q project execution and project management.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior