Process Automation Systems Lead

Overview

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 Delta

V 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.

• 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 Delta
  
  V 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 Delta
  
  V automation strategy

• 6+ years of experience within pharmaceutical or biologics manufacturing environments
• Strong Emerson Delta
  
  V experience
• Delta
  
  V 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

• 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

• Senior Automation Engineer
• Delta
  
  V Batch Engineer
• PAS Lead
• Automation Lead
• Startup / Commissioning Automation SME
• Owner-side Automation Representative