This position provides engineering support for manufacturing and facility related activities throughout the organization. Responsible for general engineering duties, including validation of equipment, support and troubleshooting of equipment / instruments, participation on client project teams, and support of Safety and Continuous Improvement efforts. The position is also responsible for specification and purchase of new process equipment and will manage small capital projects under $75,000.
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.
Coordinate small capital projects and work with internal cross-functional teams, vendors and contractors to ensure that projects remain on time and within budget.
Job Knowledge Required:
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
Ability to contribute within cross-functional teams