Facilities Engineer I (445)

Equal Opportunity Employer

　

Purpose of the Position:

The position provides engineering support for manufacturing and facilities related issues across the organization. It is responsible for general engineering duties, including support and troubleshooting of equipment / instruments, support of Facilities projects, support of equipment installations, and supporting Safety and Continuous Improvement efforts. The position is also responsible for specification and purchase of new facility equipment and will manage small capital projects.

　

　

　

Key Job Responsibilities:

Provide engineering support to all departments with a primary focus on Manufacturing and Facilities.

Diagnose problems and support all required mechanical and electrical repairs on facility and process equipment, including HVAC, USP water, and chemical distribution.

Act as primary owner for facility and process equipment failures and serve as the lead on equipment investigations conducting formal root cause investigations and generation of supporting documentation, as appropriate.

Coordinate, perform, and/or oversee technical facilities project work and equipment installations and validations.

Participate in Manufacturing Equipment Meeting and communicate progress related to CAPAs and CCRs.

Responsible as first line responder to equipment issues during manufacture including being available on call for emergency support.

Interface with equipment vendors.

Supports the creation and/or revision of Equipment SOPs including operation, maintenance, and cleaning procedures, as well as other related documents.

Support preventative maintenance and calibration of equipment and systems.

　

　

　

Job Knowledge Required:

B.S. Degree in Mechanical, Chemical Engineering, or Electrical Engineering

0 - 2 years of manufacturing support with preferred 2 years in an FDA regulated environment

Knowledge of pharmaceutical unit operations, general mechanical/electrical engineering concepts, process and equipment design, controls hardware/software, and an understanding of GMP regulations.

Hands-on ability to start-up and troubleshoot equipment

Ability to contribute to cross-functional teams