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