C&Q Engineer

PSC Biotech • Thousand Oaks, CA

2d • $95,000 - $115,000 • Hybrid

About The 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.

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.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Chemistry, Biology, or a related technical discipline.
• 5–10 years of relevant professional experience supporting commissioning and qualification, analytical instrumentation, computerized equipment, or closely related activities within a regulated environment.
• Extensive experience working with analytical laboratory equipment and instrumentation.
• Demonstrated knowledge of computerized equipment utilizing vendor-supplied or proprietary software.
• Strong understanding of qualification documentation, including the ability to review and approve protocols and related deliverables.
• Experience serving as an Equipment System Owner, technical owner, or in a comparable equipment oversight capacity strongly preferred.
• Combination of analytical testing experience and computerized equipment experience strongly preferred.
• Experience working with standalone COTS systems and network-connected data storage environments preferred.
• Strong technical documentation review skills and attention to detail.
• Ability to effectively collaborate with validation teams, engineering groups, equipment vendors, and other cross-functional stakeholders.
• Ability to work primarily on-site, with limited remote work as appropriate for documentation activities.
• Ability to support a long-term project engagement and transition equipment ownership upon project completion.
• Must be authorized to work in the U.S.
• No C2C at this time.

Nice To Haves

• Experience serving as an Equipment System Owner, technical owner, or in a comparable equipment oversight capacity strongly preferred.
• Combination of analytical testing experience and computerized equipment experience strongly preferred.
• Experience working with standalone COTS systems and network-connected data storage environments preferred.

Responsibilities

• Serve as the Equipment System Owner for computerized analytical instrumentation throughout commissioning and qualification activities.
• Provide technical ownership and oversight for COTS analytical instruments utilizing vendor-supplied proprietary software.
• Review qualification protocols, supporting documentation, and deliverables for technical accuracy and system-owner approval.
• Review and approve applicable project and qualification documentation.
• Participate in qualification execution meetings and provide system-owner input throughout project activities.
• Support equipment integration with network infrastructure for data storage while maintaining local instrument testing and operation.
• Provide expertise related to analytical instrumentation, computerized equipment, and associated data considerations.
• Collaborate with validation resources, engineering personnel, vendors, and other project stakeholders to support successful equipment qualification.
• Support issue resolution and provide technical input when questions arise during qualification activities.
• Maintain appropriate system-owner documentation throughout the project lifecycle.
• Facilitate an effective knowledge transfer and handoff to the designated long-term Equipment System Owner upon project completion.

Benefits

• 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, 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level