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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 seeking an experienced CQV Project Lead to lead and oversee Commissioning and Qualification (C&Q) activities for pharmaceutical manufacturing projects. The CQV Project Lead will be responsible for the successful mobilization and leadership of C&Q teams, management of project schedules and resource forecasts, and delivery of C&Q activities in accordance with GMP requirements and project objectives. The ideal candidate will possess strong technical and project management expertise within pharmaceutical API manufacturing and/or peptide purification facilities and have a proven track record of delivering complex C&Q programs from planning through project completion.
This is a full role based in Hunstville, AL, with an anticipated start of late October.
- Lead and manage C&Q projects across the full project lifecycle, ensuring alignment with scope, schedule, budget, and quality objectives.
- Ensure successful mobilization, onboarding, and deployment of C&Q personnel to support project execution.
- Develop and maintain project schedules, resource forecasts, staffing plans, and workload projections.
- Provide oversight and leadership for all commissioning, qualification, and validation activities, including planning, execution, documentation, and closeout.
- Coordinate and manage C&Q deliverables, including commissioning protocols, IQ/OQ/PQ execution, reports, and turnover packages.
- Collaborate with Engineering, Quality Assurance, Operations, Manufacturing, and external stakeholders to ensure project success.
- Track project progress, identify risks and issues, and implement mitigation plans to maintain project timelines.
- Manage vendors, contractors, and consulting partners supporting C&Q execution.
- Ensure all CQV activities are performed in compliance with GMP, FDA, EMA, and applicable regulatory requirements.
- Provide regular project updates, resource reports, and status communications to clients and senior leadership.
- Drive continuous improvement initiatives and promote best practices in C&Q project execution.
Requirements
- Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
- 8+ years of experience in CQV, Validation, Engineering, or Technical Project Management within the pharmaceutical, biotechnology, or life sciences industry.
- Demonstrated experience managing C&Q teams and overseeing large-scale commissioning, qualification, and validation programs.
- Experience with pharmaceutical API manufacturing facilities and/or peptide purification operations is required.
- Proven ability to develop and manage project schedules, resource forecasts, staffing plans, and project budgets.
- Strong knowledge of CQV lifecycle activities, including commissioning, FAT/SAT, IQ, OQ, PQ, and validation documentation.
- Experience applying risk-based CQV methodologies and industry best practices.
- Thorough understanding of GMP, FDA, EMA, ICH, and other applicable regulatory requirements.
- Excellent leadership, communication, stakeholder management, and problem-solving skills.
- Experience managing multiple vendors, contractors, and cross-functional project teams.
- Proficiency with project management and scheduling tools such as Microsoft Project, Smartsheet, Primavera P6, or equivalent.
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 Biotech 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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