The Role
Leads commissioning, qualification, and validation projects for pharmaceutical and biotechnology manufacturing environments. Manages multidisciplinary teams, schedules, budgets, validation protocols, documentation, risks, contractors, and regulatory compliance. Coordinates facility, utility, equipment, automation, and process implementation activities from project initiation through operational readiness and closeout, using Kneat Gx digital validation systems.
Summary Generated by Built In
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 decide 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 an experienced CQV Project Manager to lead the planning and execution of commissioning, qualification, and validation activities supporting complex pharmaceutical and biotechnology manufacturing projects. This role will oversee multidisciplinary project teams responsible for the implementation of new equipment, facility upgrades, process changes, and manufacturing expansions within regulated GMP environments.
The ideal candidate will combine strong technical CQV expertise with proven project leadership skills, ensuring projects are delivered safely, compliantly, and on schedule. This individual will serve as a key liaison between engineering, quality, manufacturing, automation, and external partners while driving execution from project initiation through operational readiness and project closeout.
- Lead CQV activities supporting facility, utility, equipment, automation, and process implementation projects.
- Develop and manage project schedules, resource plans, budget forecasts, and execution strategies.
- Coordinate cross-functional teams consisting of engineering, quality, manufacturing, validation, automation, maintenance, and vendor personnel.
- Provide oversight for protocol development, field execution, discrepancy resolution, and final report completion.
- Monitor project progress, identify risks, and implement mitigation plans to support critical project milestones.
- Manage validation deliverables throughout the document lifecycle, ensuring compliance with applicable quality and regulatory requirements.
- Facilitate project meetings and provide routine status updates to stakeholders and leadership teams.
- Support change management initiatives, quality systems activities, and project documentation workflows.
- Ensure project activities align with industry standards, GMP requirements, and internal quality systems.
- Coordinate multiple contractors and partners while maintaining clear accountability for deliverables and timelines.
- Support commissioning and qualification activities during startup, shutdown, and operational readiness phases.
- Foster a culture of safety, compliance, collaboration, and continuous improvement across project teams.
Requirements
- Bachelor's degree in Engineering, Biotechnology, Life Sciences, Pharmaceutical Sciences, or a related technical discipline.
- 8+ years of experience within the pharmaceutical, biotechnology, medical device, or life sciences industry.
- 3+ years of experience leading CQV, validation, engineering, or capital project teams.
- Demonstrated success delivering commissioning, qualification, validation, startup, or lifecycle management projects in regulated manufacturing environments.
- Hands-on experience managing CQV programs utilizing Kneat Gx digital validation systems.
- Experience supporting large-scale facility expansions, technology transfers, new product introductions, or manufacturing process improvements.
- Previous biologics, aseptic processing, cell culture, or protein manufacturing experience is highly preferred.
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
- Fitness Perks and Discounted Rates
- 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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Skills Required
- Bachelor’s degree in Engineering, Biotechnology, Life Sciences, Pharmaceutical Sciences, or a related technical discipline
- 8+ years of experience in the pharmaceutical, biotechnology, medical device, or life sciences industry
- 3+ years of experience leading CQV, validation, engineering, or capital project teams
- Demonstrated success delivering commissioning, qualification, validation, startup, or lifecycle management projects in regulated manufacturing environments
- Hands-on experience managing CQV programs using Kneat Gx digital validation systems
- Experience supporting large-scale facility expansions, technology transfers, new product introductions, or manufacturing process improvements
- Biologics, aseptic processing, cell culture, or protein manufacturing experience
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The Company
What We Do
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support. To date, PSC Biotech Corporation now serves 1000 clients in more than 35 countries worldwide through professional services consulting, cloud-based software solutions, pharmaceuticals contract manufacturing, life science investment consulting, and metrology services. PSC Biotech Corporation has six unique divisions within the parent company – each representing one of our areas of expertise: PSC Biotech, PSC Software, BioTechnique™, PSC Partners, PSC Metrology and PSC Investments. Additionally, PSC Asia and PSC Biotech Ltd represent PSC Biotech Corporation in Asia and Europe, respectively. Together, these divisions enable us to meet the ever-changing needs of our clients with a commitment to excellence and superior quality.
