We’re seeking an experienced Lead Automation Engineer to take technical ownership of automation systems across sterile drug product manufacturing and fill‑finish operations.
You’ll provide leadership during design, commissioning, and ongoing support of process control systems, ensuring reliable, compliant, and efficient production.
Key Responsibilities
Lead automation scope for new capital projects and upgrades.
Oversee automation system lifecycle activities.
Manage integration of PLC/SCADA/DCS systems with MES and data historians.
Define and enforce automation standards, network architecture, and cybersecurity compliance.
Coordinate automation contractors, OEMs, and cross‑functional teams.
Own automation change control, deviation management, and software release procedures under GMP.
Support audit readiness and inspection responses for automation and data integrity topics.
Mentor junior automation engineers and act as subject matter expert for process automation.
Requirements
Bachelor’s or Master’s degree in Automation, Electrical, or Control Engineering.
8+ years of automation experience in GMP sterile/aseptic or pharma manufacturing.
Proven leadership of multi‑system automation projects (Siemens, Rockwell, or B&R platforms).
Working knowledge of MES (e.g., Werum PAS‑X), SCADA/HMI systems, and PLC programming.
Familiarity with GAMP 5, 21 CFR Part 11, Annex 11, and data integrity requirements.
Fluent English; German proficiency advantageous.
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