Automation Process Engineer

PSC Biotech • Pomona, CA

18h

About The Position

PSC Biotech is hiring an experienced Automation Process Engineer to support the execution and lifecycle management of automation and computerized systems in a regulated life sciences environment. The role covers automation-related change controls, system documentation, commissioning and acceptance testing, risk assessments, and engineering project activities. The successful candidate will bring hands-on experience modifying PLCs and process control systems, maintaining computerized system lifecycle documentation, and commissioning automated equipment and systems.

The engineer will work with Engineering, Automation, Quality, Validation, Manufacturing, and other stakeholders to carry out automation and engineering initiatives and maintain project and system documentation in accordance with site procedures and regulated-industry requirements. PSC Biotech describes its global, multicultural team as focused on professional growth, coaching, and employee development.

Requirements

• Bachelor’s degree in Engineering, Automation, Chemical Engineering, Electrical Engineering, Computer Engineering, or a related technical discipline.
• 7–10 years of relevant experience in automation, process engineering, controls engineering, or a related engineering function within a regulated environment.
• Demonstrated experience supporting PLC modifications and Process Control System (PCS) updates.
• Experience with PI Historian systems and automated reporting systems.
• Experience authoring and maintaining computerized system lifecycle documentation, such as URS, FRS/FDS, CS, SDS, HDS, and RS documentation.
• Hands-on experience drafting and executing Acceptance Testing and Commissioning protocols and associated reports.
• Experience with engineering change management processes, including Change Controls, ECNs, and issue resolution.
• Working knowledge of equipment and system risk assessments, including evaluation of CPPs and CQAs.
• Experience supporting commissioning and implementation of automated manufacturing or process equipment.
• Demonstrated ability to manage engineering projects, priorities, documentation, and cross-functional deliverables.
• Strong technical writing, documentation, communication, and problem-solving skills.
• Ability to work effectively with Engineering, Quality, Validation, Manufacturing, and Automation stakeholders in a regulated environment.
• Must be authorized to work in the U.S.
• No C2C at this time.

Responsibilities

• Generate, present, manage, and close Engineering Automation Change Controls for automation and equipment projects.
• Support automation changes involving PLCs, Process Control Systems (PCS), PI Historian systems, Vantagepoint reporting, and equipment commissioning.
• Author and maintain computerized system lifecycle documentation, including URS, FRS/FDS, CS, SDS, HDS, and RS documents.
• Develop and update engineering documentation, including job plans, system drawings, calibration data sheets, SOPs, work instructions (WRKs), and forms (FRMs).
• Draft, execute, and document Acceptance Testing and Commissioning protocols, including final reports.
• Initiate, manage, and support resolution of Engineering Change Notices (ECNs) and project Issues Logs.
• Perform system and equipment risk assessments, including evaluating Critical Process Parameters (CPPs) associated with system Critical Quality Attributes (CQAs).
• Provide project management support for automation and engineering initiatives, coordinating activities, documentation, deliverables, and issue resolution.
• Collaborate with Engineering, Automation, Quality, Validation, Manufacturing, and other cross-functional stakeholders to support project execution.
• Maintain project and system documentation in accordance with site procedures and regulated-industry requirements.

Benefits

• Medical, dental, and vision coverage; PSC pays 100% of 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: Senior