Operations Engineer I

About the role

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).

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.

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: regularly required to stand and talk or hear; frequently required to use hands to finger, handle, or feel and reach with hands and arms; occasionally required to walk; sit; climb or balance and stoop, kneel, crouch, or crawl; must occasionally lift and/or move up to 50 pounds.
• Work environment: varies to include office atmosphere, clean room aseptic manufacturing areas, mechanical utility spaces, walk-in cold/warm/freezer rooms, warehouse, and outside (e.g., roof); environmental conditions include moderate temperature fluctuations, moderate humidity, and moderate noise levels; close proximity to hazardous utilities, fumes, or chemicals is possible; occasional exposure to moving mechanical parts; toxic or caustic chemicals.