Job DescriptionYour RoleWe 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.
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
- Fitness Perks and Discounted Rates
- Financial Perks and Discounts
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