The Role
Manage full commissioning, qualification, and validation (CQV) lifecycle projects for pharmaceutical clients. Responsibilities include project planning, scheduling, budgeting, risk mitigation, regulatory compliance, stakeholder communication, and vendor or contractor coordination. The role applies risk-based CQV methodologies, supports project initiation through closure, and requires strong analytical, problem-solving, quality, and compliance skills. Travel may be required for client assignments and project engagements.
Summary Generated by Built In
This is a remote position.
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
Our CQV Project Managers deliver comprehensive support to clients throughout every stage of the CQV lifecycle. They 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.
Requirements
- Bachelor's degree in related engineering discipline.
- 10 years of Commissioning, Qualification, and Validation experience in the pharmaceutical industry.
- Experienced managing full CQV lifecycle projects. Highly skilled in project planning and scheduling, budget management, risk mitigation, stakeholder communication, and vendor/contractor coordination.
- Well-veresed 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.
- 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
- Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more).
- Financial Perks and Discounts
Adhering to U.S Requirements on salary transparency, the salary bracket for this role is set between $100,000 - $135,000 annually. The offered salary may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.
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 a related engineering discipline
- 10 years of Commissioning, Qualification, and Validation experience in the pharmaceutical industry
- Experience managing full CQV lifecycle projects
- Expertise in project planning and scheduling
- Expertise in budget management
- Expertise in risk mitigation
- Expertise in stakeholder communication
- Experience coordinating vendors and contractors
- Knowledge of the 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
- Willingness and ability to travel as needed for project assignments and client engagements
- Authorization to work in the United States
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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.
