Process/Project Engineer II

Key Responsibilities

• Provide engineering support and guidance to Manufacturing, Facilities and Validation.
• Create Engineering documentation including technical reports, specifications, URDs, CAD drawings, and ETOPs.
• 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 expert 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.
• Provide technical oversight and lead the FMEA and business risk management process.
• Lead and participate in Continuous Improvement efforts to improve efficiency and reduce cost.
• Cook large capital projects and oversee internal cross-functional teams, vendors and contractors to ensure that projects remain on time and within budget.
• Lead and participate in Continuous Improvement efforts to improve safety, quality, and efficiency and to reduce cost.

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.
• 5 years of manufacturing support with minimum of 2 years in a chemical API environment.
• Hands-on ability to start-up and troubleshoot of equipment.
• Ability to facilitate and lead cross-functional teams.

Pay

The annualized salary range for this role is $95,900.00 - $117,300.00.