Process/Project Engineer

Key Responsibilities

• Provide engineering support to Manufacturing and Facilities.
• Create Engineering documentation including technical reports, specifications, URDs, CAD drawings, and ETOPs.
• Develop and execute validation protocols.
• Create and revise equipment SOPs, preventive maintenance procedures and other documents needed to support equipment operation.
• Participate in client project teams as the Engineering representative.
• Responsible as a first line responder on equipment issues during manufacture which includes being available on-call for emergency support.
• Obtain general knowledge on process equipment.
• Train technical personnel in the use, care and safe operation of manufacturing/facilities assets.
• Collaborate with necessary departments to investigate and close CAPAs and resolve production problems.
• Participate in Safety and Continuous Improvement efforts to improve safety, efficiency and reduce cost.
• Cook up and coordinate small capital projects and work with internal cross-functional teams, vendors and contractors to ensure that projects remain on time and within budget.

Required Skills/Abilities

• B.S. Degree in Chemical, Mechanical or Electrical Engineering.
• Knowledge of pharmaceutical unit operations, general mechanical/electrical engineering concepts, process and equipment design, controls hardware/software, and an understanding of GMP regulations.
• 0 to 5 years of manufacturing support with preferred 2 years in an FDA regulated environment.
• Hands-on ability to start-up and troubleshoot of equipment.
• The annualized salary range for this position is between $83,000.00 - $96,300.00.