Automation Compliance Engineer

PSC Biotech•Pomona, CA

2d•$55 - $57

About The Position

PSC Biotech is hiring Automation Compliance Engineers to support engineering automation projects in regulated life sciences manufacturing environments. The role focuses on change control, computerized system lifecycle documentation, commissioning, and compliance activities. The engineer supports automation systems and equipment to ensure modifications, upgrades, and commissioning work are documented, tested, executed, and closed in accordance with applicable procedures and project requirements. The role collaborates with engineering, automation, commissioning, and other cross-functional stakeholders to execute and document system changes. It also ensures project documentation is accurate, complete, and maintained throughout the system and project lifecycle. Applicants must be authorized to work in the U.S.; C2C arrangements are not available.

Requirements

Bachelor’s degree in Engineering, Automation, Computer Science, or a related technical discipline preferred.
5–7 years of relevant experience supporting automation, engineering, commissioning, validation, or compliance activities within a regulated environment.
Experience with Change Control and Engineering Change Notice (ECN) processes.
Experience authoring and maintaining computerized system lifecycle documentation such as URS, FRS/FDS, CS, SDS, HDS, and RS documents.
Experience drafting and executing Acceptance Testing and Commissioning protocols and preparing associated reports.
Working knowledge of automation and control systems, including PLCs, PCS platforms, and PI Historian systems.
Experience creating or maintaining technical documentation such as system drawings, calibration datasheets, SOPs, work instructions, job plans, and controlled forms.
Strong technical writing, documentation, organization, and problem-solving skills.
Ability to work effectively across engineering and technical teams while managing multiple documentation and compliance activities.
Must be authorized to work in the U.S.

Responsibilities

Generate, manage, present, and close Change Controls associated with Engineering Automation projects.
Support automation changes involving Programmable Logic Controllers (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.
Draft, execute, and complete Acceptance Testing and Commissioning protocols, including preparation of final reports.
Create and update engineering and operational documentation, including job plans, system drawings, calibration datasheets, SOPs, work instructions (WRKs), and forms (FRMs).
Initiate and manage Engineering Change Notices (ECNs) and issue logs through resolution and closure.
Support documentation and compliance requirements associated with modifications to automation systems and manufacturing equipment.
Collaborate with engineering, automation, commissioning, and other cross-functional stakeholders to support execution and documentation of system changes.
Ensure project documentation is accurate, complete, and appropriately maintained throughout the system and project lifecycle.

Benefits

Medical, dental, and vision insurance; PSC pays 100% of qualifying employee medical premiums and 50% for qualifying dependents.
Employee Assistance Program insurance options.
Basic Life Insurance.
Long Term Disability.
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.