Process Equipment Engineer

PSC Biotech•Irvine, CA

1d•$80,000 - $110,000

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 Process Equipment Engineer! The Process Equipment Engineer is responsible for the lifecycle management, performance, and reliability of process equipment used in pharmaceutical manufacturing. This role supports GMP-compliant operations by ensuring process equipment is properly designed, installed, qualified, maintained, and optimized to meet production, quality, safety, and regulatory requirements. The engineer partners closely with Manufacturing, Quality, Validation, and Facilities teams to support reliable and compliant manufacturing operations.

Requirements

Bachelor’s degree in Mechanical, Chemical, Biomedical, or related Engineering discipline
3–7 years of experience supporting process equipment in a pharmaceutical, biotech, or GMP-regulated manufacturing environment
Strong working knowledge of GMP/cGMP regulations and equipment compliance expectations
Experience supporting equipment qualification, validation, and lifecycle management
Familiarity with biopharmaceutical process equipment (e.g., bioreactors, filtration systems, chromatography skids, CIP/SIP systems, autoclaves, or related equipment)
Experience with change control, deviations, and technical documentation in a regulated environment
Ability to troubleshoot complex equipment issues and support manufacturing operations on the floor
Strong communication skills and ability to work cross-functionally
Experience working with vendors and external service providers
Must be authorized to work in the U.S.
No C2C at this time.

Responsibilities

Serve as technical owner for assigned process equipment and systems used in pharmaceutical manufacturing.
Support equipment design, specification, installation, and commissioning activities.
Lead and support equipment qualification and validation activities (IQ/OQ/PQ) in compliance with GMP requirements.
Provide day-to-day manufacturing floor support, including troubleshooting equipment and process issues.
Collaborate with Manufacturing, Quality, Validation, and Facilities to ensure equipment is fit for intended use.
Support change control, deviations, CAPAs, and risk assessments related to process equipment.
Develop and review engineering and technical documentation, including URSs, SOPs, and maintenance strategies.
Coordinate with vendors and contractors for equipment service, modifications, and technical support.
Drive continuous improvement initiatives focused on equipment performance, uptime, and compliance.