Senior Manager Manufacturing System Engineering - Bulk Drug Substance - Upstream

Senior Manager Manufacturing System Engineering (Bulk Drug Substance - Upstream)

What You Will Do / Responsibilities
- Build and lead the Automation Engineering team; main point of contact for the function.
- Support design reviews with corporate engineering.
- Commission and qualify process equipment automation in alignment with GMP; ensure operational capability, GMP compliance, and on-time delivery.
- Collaborate with site process engineering to develop process control automation solutions (primarily Emerson DeltaV DCS).
- Support commissioning/qualification (Automation Installation Verification/Automation Check Out).
- Partner on operational readiness, document reviews, deviation investigations, and change controls.
- Mentor to develop site automation capabilities.
- Lead automation system administration, OS/HotFix assessments and rollout, maintenance, spare parts management, and departmental SOP ownership.
- Provide 24/7 onsite/on-call automation support; troubleshoot; lead daily manufacturing/engineering meetings.
- Manage priorities and staff development; drive continuous improvement and knowledge sharing.
- Conduct automation change assessments; implement configuration changes; support qualification runs.
- Represent automation in cross-functional design reviews/audits.
- Maintain data integrity per Amgen and industry standards; troubleshoot and resolve process/system issues.
- Manage budgeting for Automation engineering; forecast/manage expenditures.
- Participate in tech and commissioning readiness for startup operations; up to 10% travel.

What We Expect Of You (Required)
- High school/GED + 12 yrs, or Associate + 10 yrs, or Bachelor + 8 yrs, or Master + 6 yrs, or Doctorate + 2 yrs engineering experience.
- Minimum 2 years experience directly managing people and/or leading teams/projects/programs/resource allocation.

Preferred Qualifications / Skills
- Degree in Electrical Engineering, Computer Science, Chemical Engineering, or Biotech Engineering.
- Emerson DeltaV; process control network and Virtual Infrastructure; OPC, Foundation Fieldbus, Profibus.
- IO-Link for smart sensor/actuator integration.
- PAT tools/strategies; OEM software/instrument integration.
- Industry standards: 21 CFR Part 11, ASTM 2500, S88, S95, GAMP, GDP, GMP.
- Regulated environment experience (cGMP/OSHA/EPA), regulatory interaction; change control, CAPA, and validation/qualification.
- Tech transfer, process design, commissioning & qualification.
- Biopharma facility knowledge (upstream/downstream; CIP/SIP).
- Strong leadership, technical writing, and communication/presentation; flexibility for 24/7 operations and occasional after-hours coverage.