Operations Engineer I
About The Position
The Operations Engineer is responsible for equipment, facility, and utility (EFU) lifecycle management. This includes managing the specification, procurement, installation, and commissioning of new EFU assets; contributing to the development of calibration, maintenance, operation, and cleaning procedures; providing technical support to end user, quality, and maintenance personnel; and managing the decommissioning of EFU assets to be retired. The Operations Engineer is quality-centered and follows company standard operating procedures (SOPs) geared toward FDA and other applicable regulations and in-line with current good manufacturing practices (cGMPs).
Requirements
- Bachelor’s degree in an applicable engineering discipline (ex. chemical, biomedical, mechanical, electrical, etc.) with 0-2 years professional experience in a biologics/pharmaceutical (clinical development or commercial manufacturing) environment.
- Associate’s degree in an applicable discipline with 3-5 years professional experience in a biologics/pharmaceutical (clinical development or commercial manufacturing) environment.
- Performance of Essential Duties and Responsibilities for low-complexity unit operations with moderate input from management and moderate-complexity unit operations with high input from management.
- Excellent written and verbal communication skills.
- Ability to adapt to changing regulatory, client, and company requirements; new technologies; and shifting priorities.
- Ability to travel (typically <5%) for training and/or EFU testing
- Ability to work flexible hours and inconsistent schedules as necessary to meet production demands and timelines.
Responsibilities
- Manage the development of EFU user requirement specifications (URS) and functional requirement specifications (FRS).
- Assess the impact of EFU on cGMP compliance and patient health and safety.
- Author, execute, review, and/or approve commissioning plan, factory acceptance test (FAT), and site acceptance test (SAT) documents.
- Assimilate information from regulatory, guidance, and technical documents; EFU manufacturers and service personnel; and Cytovance resources to create operation, calibration, and preventive maintenance procedures.
- Train end user, quality, and maintenance personnel on EFU procedures.
- Create and maintain engineering drawings.
- Assist in the administration of EFU software packages (ex. CMMS, SCADA, etc.).
- Provide technical troubleshooting and creative solutions to manufacturing process challenges.
- Provide support during regulatory inspections and customer audits. Identify and implement quality system improvements when gaps are identified through audits and departmental reviews.
- May provide direction to junior personnel on an as needed basis but has no formal reports
- Additional duties as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
