Description

You will manage mid-to-large scale engineering projects within a cGMP manufacturing environment.

This role is on-site.

Responsibilities

• Manage project scope, schedules, and costs by tracking cross-functional teams and contractors.
• Develop and execute commissioning plans for process and utility systems and equipment.
• Review process flow diagrams and piping and instrumentation drawings (P&IDs) for new and modified systems.
• Lead investigations into process systems to determine root causes and implement CAPAs.
• Direct capital projects, including the creation of expenditure requests and purchase requisitions.

Required Skills

• 10+ years of engineering experience in cGMP Food, Pharmaceutical, or Biological manufacturing.
• Bachelor's degree in Mechanical, Biochemical, or Chemical Engineering.
• Experience with P&IDs and process flow diagrams.
• Proficiency in technical writing for engineering evaluations, change controls, and testing plans.
• Ability to use statistical tools for data analysis, trend prediction, and process capability measurement.
• Experience managing capital projects and contractor activities.
• Knowledge of FDA submission documentation requirements.

Preferred Skills

• Skill in developing preventative maintenance (PM) plans and troubleshooting manufacturing equipment.
• Serve as the technical liaison for OSHA, regulatory, and other facility-related audits.

Key Skills

Education

Bachelor's degree