Demo

Commissioning Agent

PSC Biotech
San Francisco, CA Full Time
POSTED ON 2/22/2025
AVAILABLE BEFORE 5/20/2025

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 decide 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 an experienced Commissioning Agent to provide comprehensive Commissioning Services for Facilities Capital Projects. In this role, you will be responsible for ensuring the successful commissioning of systems and equipment, from design through to post-handover. You will oversee and coordinate all commissioning activities to ensure systems are properly tested, validated, and ready for operational use, in line with project specifications and industry standards.

  • Lead the commissioning process from the design phase through to system handover, ensuring all systems meet commissioning readiness requirements.
  • Develop and implement Commissioning Plans and Protocols for each project, ensuring alignment with industry best practices and project requirements.
  • Perform detailed design reviews, ensuring systems are feasible for commissioning and meet regulatory and operational standards.
  • Oversee the pre-functional and functional testing of systems, ensuring that all testing is completed and documented in compliance with Good Engineering Practices (GEPs).
  • Coordinate system performance validation, ensuring that systems are tested thoroughly and are ready for operational use.
  • Maintain and update the issues log, tracking any identified problems and ensuring timely resolution.
  • Regularly report progress on commissioning activities to project teams, highlighting key milestones and any issues that need attention.
  • Collaborate with cross-functional teams to ensure that commissioning activities align with the overall project schedule and objectives.
  • Ensure the proper documentation of commissioning activities, including testing reports, validation protocols, and final commissioning reports.
  • Support post-handover activities, ensuring any warranty issues are addressed and systems continue to meet performance standards.
  • Attend required trainings as needed.
  • Ensure compliance with industry regulations and requirements always.
  • Additional responsibilities as required.

Requirements

  • Bachelor's degree in related engineering discipline.
  • 5 years or more of commissioning, qualification, and validation engineering experience in the pharmaceutical / life science industry.
  • Proven success in managing, reviewing, authoring, and approving full lifecycle technical documentation.
  • Strong understanding of engineering specifications and requirements.
  • Experienced generating and executing CQV activities on a range of equipment and systems.
  • Proven success in managing commissioning projects, developing and executing Commissioning Plans, and overseeing testing activities.
  • Strong understanding of engineering specifications, system performance validation, and adherence to industry regulations.
  • Experience coordinating with cross-functional teams, vendors, and ensuring all stakeholders are aligned with project schedules and deliverables.
  • 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.
  • 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 rates at Anytime and 24-Hour Fitness
  • Financial Perks and Discounts
  • Estimated Annual Salary (dependent on experience) $90,000 - $120,000

    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.

    LI-DC1

    Requirements

    Bachelor's degree in related engineering discipline. 6 years of experience writing and executing CQV documentation in the pharmaceutical / life science industry. Strong understanding of regulatory requirements. Strong technical writing skills and proven experience writing and developing validation and commissioning protocols. Strong analytical skills with the ability to problem-solve and troubleshoot effectively. Detail-oriented mindset with a commitment to maintaining high-quality standards. Excellent communication and interpersonal skills, with the ability to work collaboratively in a team environment. 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.

    Salary : $90,000 - $120,000

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