Specialist CTU Engineer – Equipment & Facility Support

About the role

The Controlled Temperature Unit (CTU) Specialist provides day‑to‑day engineering support for CTU equipment and facilities, ensuring compliance with cGMP, safety, and environmental regulations while meeting cost goals.

Key responsibilities

• Support and monitor equipment performance, conduct maintenance, and develop improvement plans.
• Lead troubleshooting of process equipment, execute lock‑out/tag‑out (LOTO) procedures, and manage spare‑parts inventory.
• Maintain accurate CMMS/EAM data, schedule preventive, predictive, and corrective maintenance, and develop reliability metrics.
• Collaborate with operations, maintenance, and quality teams on deviations, audits, and regulatory inspections.
• Serve as project engineer for equipment upgrades, qualification, and commissioning activities.

Required profile

• B.S. in Engineering, Science, or Engineering Technology with at least 2 years of relevant experience.
• Demonstrated ability to work independently and in cross‑functional teams.
• Experience with equipment troubleshooting, continuous improvement projects, and maintenance data management.
• Knowledge of engineering standards (ASME, IEEE, NFPA, CFR 1910, NIST, ANSI).

Required skills

• Equipment troubleshooting and maintenance
• CMMS/EAM systems (SAP, Maximo, etc.)
• LOTO procedures
• Root Cause Analysis, FMEA
• Lean Six Sigma methodology
• cGMP compliance for pharmaceutical manufacturing
• Reliability engineering and asset life‑cycle management