Analytical Systems Specialist

PSC Biotech • Ventura, CA

6h • $115,000 - $125,000 • Onsite

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. 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 hiring an experienced Analytical Systems Specialist to join our team! The Analytical Systems Specialist supports manufacturing and laboratory operations within a GMP -regulated environment by ensuring analytical systems are compliant, reliable, and fit for intended use. This role partners closely with business process owners, Quality, Manufacturing, and Facilities & Engineering to support the full lifecycle of analytical systems, including implementation, upgrades, data integrity oversight, and continuous improvement initiatives. This role contributes to cross -functional projects involving analytical technologies, data review and trending, documentation, and regulatory compliance, while maintaining strict adherence to safety, quality, and cleanroom requirements.

Requirements

• Degree in Engineering, Life Sciences, or a related discipline.
• 6+ years relevant experience supporting GMP manufacturing, laboratory operations, analytical systems, engineering, process development, or technical support roles.
• Experience supporting analytical equipment, computerized systems, or laboratory technologies within a regulated environment.
• Working knowledge of GMP principles, data integrity, and analytical testing within pharmaceutical or biotech manufacturing.
• Experience supporting system implementation, commissioning and qualification, or change control activities.
• Strong data analysis and trending skills; experience reviewing and verifying analytical data.
• Ability to author clear, compliant technical and GMP documentation.
• Experience working in cross -functional teams and supporting complex projects.
• Strong communication skills, with the ability to present technical information to diverse audiences, including operations, quality, and leadership.
• Proficiency with common manufacturing and quality systems (e.g., document management, change control, deviation/CAPA systems) and data tools such as Excel/Trackwise or similar platforms.
• Ability to work independently, manage priorities, and operate effectively in a dynamic, regulated environment.
• Ability to work on -site in manufacturing and laboratory areas.
• Willingness to support flexible work schedules as required by production and project needs.
• Ability to work in cleanroom environments while adhering to gowning, safety, and GMP requirements.
• Must be authorized to work in the U.S.
• No C2C at this time.

Responsibilities

• Support analytical system lifecycle activities, including implementation, commissioning, qualification, upgrades, and ongoing system performance within a GMP manufacturing and laboratory environment.
• Partner with business process owners and cross -functional stakeholders to ensure analytical systems remain compliant with global regulatory expectations and aligned with operational needs.
• Perform analytical data review and verification within validated systems, including assessment of invalid results, trend analysis, and data integrity oversight.
• Develop and support Testing Result Assessments (TRAs), including evaluation of method trending data.
• Collaborate with Quality and subject matter experts to support root cause investigations and the identification and implementation of corrective and preventive actions.
• Author, review, and revise GMP documentation such as SOPs, forms, and system -related documentation to ensure alignment with current operations.
• Support change control activities, including process impact assessments, system upgrades, and introduction of new analytical technologies.
• Participate in audit trail reviews, data integrity assessments, and review of computerized system validation documentation.
• Contribute to compendial and regulatory impact assessments related to analytical testing in support of global regulatory requirements.
• Apply technical, scientific, and operational knowledge to support troubleshooting efforts and continuous improvement initiatives.
• Participate in operations meetings, communicate findings effectively, and support cross -functional decision -making.
• Work on -site as required to support manufacturing schedules, including flexible shifts, while complying with cleanroom gowning, safety, and GMP requirements.

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
• Discounted rate at Anytime Fitness
• Financial Perks and Discounts

What This Job Offers

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