· Bachelor of Science Degree in engineering or equivalent is required.
· 3 to 15 years of engineering and/or project management experience preferred
· PMP Certification preferred.
· Communicate well with site operations personnel, skilled trades, site engineering and Architectural & Engineering firms.
· Solid understanding of engineering/design packages.
· Experience with Pharmaceutical/FDA regulated processes, with a working knowledge of cGMP facility/equipment requirements in aseptic filling/packaging environments.
· Demonstrates the ability to prepare and administer estimates, budgets, schedules, and the ability to manage multiple priorities.
· Strong interpersonal, teamwork and problem-solving skills.
· Excellent verbal and written skills.
· Must be familiar with a variety of sterile drug product vial processing and primary packaging equipment including washers, dehydrogenation tunnels, fillers, pluggers, cappers, and tray loaders.
· Must possess knowledge of sterile parts preparation and formulation processes and equipment.
· Experience in filled vial inspection, secondary packaging, labeling, barcoding and serialization is also beneficial.