Description

You will manage facility maintenance, engineering programs, and process equipment compliance within a cGMP environment.

Responsibilities

• Develop and implement PM plans for manufacturing equipment and establish engineering tools to maintain facility repair standards.
• Direct capital engineering projects and process improvement initiatives while facilitating equipment and parts requisitions.
• Serve as the technical expert for equipment and facilities during regulatory agency audits.
• Lead investigations into facility and maintenance deviations, training SMEs in problem-solving and corrective actions.
• Monitor manufacturing operations to identify debottlenecking opportunities and provide technical recommendations for process optimization.

Required Skills

• 5+ years of process or project engineering experience in a cGMP, pharmaceutical, or biological manufacturing environment.
• Bachelor's degree in Mechanical, Biochemical, or Chemical Engineering.
• Deep understanding of cGMP compliance for facility and maintenance operations.
• Ability to apply engineering theory to determine root causes of equipment failures.
• Experience performing equipment performance evaluations.
• Capability to write regulatory documents for FDA submission.
• Experience preparing annual operational assessment reports for critical systems.

Key Skills

Education

Bachelor's degree