Engineering Manager(Manufacturing)

Engineering Manager Manufacturing

• 5–10 years of engineering or facilities management experience in regulated manufacturing.
• Strong knowledge of cGMP, FDA, OSHA, EPA regulations, and engineering validation principles.

Summary

The Engineering Manager is responsible for overseeing manufacturing equipment, utilities, facilities, and engineering operations to ensure safe, reliable, and compliant production. This role manages capital projects, preventive maintenance, engineering documentation, and safety programs under cGMP, OSHA, EPA, and state regulations. The position requires strong leadership to guide engineers and technicians, coordinate contractors, and support continuous improvement initiatives.

Key Responsibilities:

• Equipment & Facilities — Oversee maintenance and reliability of manufacturing equipment, utilities, HVAC, and cleanroom infrastructure.
• Capital Projects — Lead expansions, installations, upgrades, and construction activities; manage CapEx budgets.
• Automation & Improvement — Implement robotics, cobots, and automation solutions; drive cost‑saving initiatives.
• Validation & Documentation — Manage SOPs, preventive maintenance systems, work orders, and validation protocols (IQ/OQ/PQ).
• Safety & Compliance — Ensure compliance with OSHA, EPA, and FDA cGMP standards; manage audits and incident investigations.
• Leadership — Supervise engineers, technicians, and facilities staff; provide training and succession planning.
• Vendor & Stakeholder Management — Coordinate contractors, suppliers, and service providers; present reports on budgets and projects.

Qualifications:

• Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, Industrial, Environmental) or equivalent.
• 5–10 years of engineering or facilities management experience in regulated manufacturing.
• Strong knowledge of cGMP, FDA, OSHA, EPA regulations, and engineering validation principles.
• Experience managing teams, contractors, and capital projects.
• Familiarity with automation systems, robotics, and advanced manufacturing technologies.