Process Equipment Engineer

PSC Biotech • Irvine, CA

3d • $80,000 - $110,000

About The Position

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.

Benefits

• W2 Temp positions offer our Medical and sick time benefits.
• Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $80,000 - $110,000 annually. The salary offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees