Senior Automation Compliance Engineer

PSC Biotech; Pomona (CA); On-site; USD 76,000 - 79,000; Full time

Benefits offered by this job

Medical, Dental, and Vision - PSC pays

401(k) and matching

PTO, Sick Time, and Holidays

Education Assistance

Pet Insurance

Fitness Perks and Discounts

Financial Perks and Discounts

Job summary

PSC Biotech is hiring an Automation Compliance Engineer to support life sciences automation projects in a regulated manufacturing environment. You will manage change controls, draft URS/FRS/FDS, and document lifecycle activities across PLCs, PCS, and PI Historian systems.

You will draft testing protocols, perform acceptance testing, and maintain engineering documentation, drawings, SOPs, and calibration datasheets while coordinating with cross-functional teams to ensure compliant project

Qualifications

• 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.

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.
• 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, and forms.
• Initiate and manage Engineering Change Notices (ECNs) and issue logs through resolution and closure.
• Support the 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 successful execution and documentation of system changes.
• Ensure project documentation is accurate, complete, and appropriately maintained throughout the system and project lifecycle.

Skills

Change Control

ECN processes

Technical writing

Documentation

Cross-functional collaboration

Education

Bachelor’s degree in Engineering/Automation/CS

Tools

PLCs

PCS platforms

PI Historian

Vantagepoint

Job description

PSC Biotech is hiring an Automation Compliance Engineer to support life sciences automation projects in a regulated manufacturing environment. You will manage change controls, draft URS/FRS/FDS, and document lifecycle activities across PLCs, PCS, and PI Historian systems.

You will draft testing protocols, perform acceptance testing, and maintain engineering documentation, drawings, SOPs, and calibration datasheets while coordinating with cross-functional teams to ensure compliant project