Operations Engineer I

General Summary:

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).

Essential Duties and 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

Job 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.

OR

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.

Physical Demands:

While performing the duties of this Job, the employee is regularly required to stand and talk or hear. The employee is frequently required to use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to walk; sit; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds.

Work Environment:

Work environment will vary to include: office atmosphere, clean room aseptic manufacturing areas, mechanical utility spaces, walk in cold/warm/freezer rooms, warehouse, and outside (ex. roof). Environmental conditions will include moderate temperature fluctuations, moderate humidity, and moderate noise levels. Close proximity to hazardous utilities, fumes, or chemicals is possible. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; toxic or caustic chemicals.