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Process Automation Systems Lead

Job

Technical Source

Wilson, NC (In Person)

Full-Time

Posted 3 days ago (Updated 1 day ago) • Actively hiring

Expires 7/12/2026

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Job Description

Technical Source is seeking an experienced PAS Owner's Representative to support a large-scale biologics manufacturing startup project. This individual will serve as the owner-side automation lead for the Buffer & Media Prep process area, acting as the primary liaison between Process Engineering, CQV, Manufacturing, and automation integration vendors. The ideal candidate brings strong DeltaV Batch expertise, biologics manufacturing experience, and the ability to lead automation activities within a fast-paced GMP startup environment. This role is heavily focused on process sequencing, troubleshooting, FAT/SAT support, cross-functional coordination, and driving technical issue resolution during commissioning and startup activities. This is not a traditional hands-on programming role. The selected individual will function as a technical owner and automation leader responsible for ensuring automation deliverables remain aligned with operational and project execution goals. Key Responsibilities Serve as the owner-side automation lead for the Buffer & Media Prep area Coordinate automation activities between Process Engineering, CQV, Manufacturing, and system integrators Support DeltaV Batch execution and process sequencing activities Lead and participate in FATs, SATs, commissioning, and startup activities Troubleshoot complex automation and process sequencing issues within GMP manufacturing systems Escalate and drive resolution of technical and schedule-related issues Ensure alignment with site and global automation standards Support automation risk assessments and startup readiness activities Collaborate closely with validation and quality teams to support GMP/CSV compliance Provide technical oversight of automation vendors and integration partners Support execution of site DeltaV automation strategy Required Qualifications 6+ years of experience within pharmaceutical or biologics manufacturing environments Strong Emerson DeltaV experience DeltaV Batch experience within GMP manufacturing operations Experience supporting biologics or pharmaceutical startup/commissioning activities Understanding of ISA-88 / batch process sequencing concepts Experience supporting Buffer & Media Prep or related bioprocess systems Experience supporting FAT/SAT execution and issue resolution
Knowledge of:
OSI PI PLC
systems Industrial automation networks OT infrastructure 21 CFR Part 11 EU GMP Annex 11 GMP/CSV requirements Preferred Qualifications Biologics greenfield startup experience Owner's Rep or embedded client-side automation leadership experience CQV coordination experience Upstream / Downstream process knowledge Vendor management and escalation experience GAMP 5 familiarity Project leadership or automation coordination experience Industry 4.0 / IoT awareness Preferred Backgrounds Senior Automation Engineer DeltaV Batch Engineer PAS Lead Automation Lead Startup / Commissioning Automation SME Owner-side Automation Representative