Pharma Automation Engineer – DCS/SCADA & 21 CFR 11

ACL Digital

Thousand Oaks (CA)

On-site

USD 110,000 - 170,000

Full time

29 hours ago

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Job summary

ACL Digital seeks engineers to support Clinical & Commercial Plant Automation programs and capital projects. Role requires strong knowledge of DeltaV DCS, Rockwell PLC, HMI, and SCADA platforms across multiple projects.

Responsibilities include project representation during implementation, post-implementation support, SOP updates, and asset management in Maximo and CMDB systems, with adherence to regulatory standards and safety practices.

Qualifications

Top 3 must-have skill sets: SCADA and PLC experience; regulatory compliance with 21 CFR Part 11.
Experience with capital construction projects and lifecycle management of manufacturing process controls.

Responsibilities

Represent Plant Automation during project implementation of new automation solutions (DeltaV DCS, Rockwell PLC, HMI, SCADA).
Post-implementation activities: hyper-care support, training System Owners, updating SOPs and training docs, delivering spare parts lists, updating Maximo assets and CMDB.
Ensure compliance to Amgen Engineering and Operational standards during design and implementation.
Support projects to integrate new drug manufacturing technologies into clinical/commercial facilities.
Perform automation assessments, implement configuration changes, support process qualification runs.
Maintain safe working environment per EH&S practices and regulations.