Automation Process Engineer (Biotech)

Location: Pomona, United States; onsite role. Must be authorized to work in the U.S.

Salary: $57–$62 per hour.

Company

hirify.global provides services to life sciences organizations, supporting the development, manufacturing, and distribution of healthcare products in compliance with regulatory requirements.

What you will do

• Manage engineering automation change controls for automation and equipment projects, including Change Controls, Engineering Change Notices, and issue logs.
• Support PLC, Process Control System, PI Historian, Vantagepoint reporting, and automated equipment changes.
• Author and maintain computerized system lifecycle documentation, including URS, FRS/FDS, CS, SDS, HDS, and RS documents.
• Develop engineering documentation such as job plans, system drawings, calibration data sheets, SOPs, work instructions, and forms.
• Draft, execute, and document acceptance testing and commissioning protocols and final reports.
• Perform system and equipment risk assessments and coordinate automation and engineering projects with Engineering, Automation, Quality, Validation, and Manufacturing stakeholders.

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 updates, including automated manufacturing or process equipment commissioning and implementation.
• Experience with PI Historian systems and automated reporting systems.
• Experience authoring and maintaining computerized system lifecycle documentation, including 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 Critical Process Parameters and Critical Quality Attributes.
• 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.

Culture & Benefits

• Medical, dental, and vision insurance; PSC pays 100% of qualifying employee medical premiums and 50% for qualifying dependents.
• Employee assistance programs, basic life insurance, long-term disability coverage, and other insurance options.
• 401(k) plan with matching, PTO, sick time, and paid holidays.
• Education assistance, pet insurance, fitness perks, and financial discounts.
• Professional coaching, development resources, and a multicultural environment.