Job Description
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.

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 hiring a dedicated CQV Project Manager. This role delivers comprehensive support to the organization throughout every stage of the CQV lifecycle. You will offer expert guidance in project planning, strategic development, and execution, employing a risk-based methodology to ensure adherence to regulatory standards and the highest levels of product safety.

• Oversee commissioning, qualification, and validation (CQV) efforts for sterile injectable manufacturing equipment and pharmaceutical site utilities.
• Develop and manage detailed project plans, timelines, and resource allocation to ensure successful delivery of CQV milestones.
• Collaborate with cross-functional teams including engineering, quality assurance, operations, and regulatory to align CQV activities with project objectives.
• Ensure all CQV activities comply with GMP, FDA, and other regulatory requirements; maintain accurate documentation and validation protocols.
• Identify potential risks in CQV processes and implement mitigation strategies to maintain project integrity and timelines.
• Manage external vendors and contractors involved in equipment installation, qualification, and validation.
• Drive process optimization and best practices for CQV methodologies within sterile injectable manufacturing environments.
• Monitor project budgets, prepare progress reports, and communicate status updates to senior leadership and stakeholders.

Requirements

• Bachelor's degree in related engineering discipline.
• 5+ years of experience managingend-to-end CQV activities for capital projects, including URS development, FAT/SAT execution, and validation documentation for GMP-compliant sterile injectable manufacturing equipment and pharmaceutical site utilities.
• 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.
• Familiarity with ATEC systems preferred.
• Travel is required. At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.
• 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 is committed to 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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