JOB SUMMARY

Provide maintenance, calibration, and technical support to the manufacturing process and facility equipment. Coordinate and perform testing and calibration on electrical, mechanical, and analytical equipment for conformance to established standards. Request purchase order requisitions for 3rd party maintenance requirements.

ESSENTIAL JOB FUNCTIONS

• Assist in creating/establishing a Maintenance and Calibration Program including recommendation of Maintenance and Calibration activities and frequencies based upon system/equipment assessments
• Plan, schedule, and perform planned and unplanned maintenance and calibration on process and facility equipment/utilities including but not limited to HVAC, freezers, cold rooms, bioreactors, filling systems, analytical testing instruments, and building management control systems
• Coordinate and support external calibration service providers
• Build relationships with customers, colleagues, and service partners to provide a collaborative approach to the operational management of lab spaces.
• Track and report on calibration status of all equipment/instruments in the facility
• Ensure timely completion of calibrations/preventive maintenance and compliant record keeping.
• Obtain required documentation and approval prior to creation of purchase order requisition for service requests to be completed by 3rd party vendors.
• After purchase order has been issued, ensure service delivery dates are correct and revise as necessary, per follow-up with suppliers and customers.
• Source, qualify, negotiate, and procure service contracts in support of lab operations.
• Ensure purchase requisitions are requisitions closed within 180 days and confirm that associated purchase orders are closed as well.
• Enter and maintain records in the Computerized Maintenance Management System (CMMS)
• Meet regularly with key stakeholders (lab staff, service partners, management) to identify, review and resolve issues in a timely manner and/or escalate as necessary.

KNOWLEDGE, SKILLS AND EXPERIENCE

• Associates Degree essential, Bachelor's degree preferred, EET preferred.
• 3-5 years related Calibration/Metrology work experience, GMP preferred.
• Ability to understand user manuals/specifications, wiring diagrams, equipment P&ID, and standard operating procedures.
• Mechanically inclined/knowledge of hand tools
• Proficient with basic computer systems including the use of a computerized maintenance management system (CMMS)
• Demonstrated interpersonal skills to build relationships, act as change agent, and adapt to rapidly changing organizational and business needs
• Ability to thrive in a quickly changing, CDMO environment where flexibility and teamwork is essential

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to work in a BSL 2 with personal protective equipment.
• While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
• In the performance of the duties of this job the employee is required to communicate using telephone and e-mail.
• While performing the duties of this job, the employee must be aware of potential exposure to moving mechanical parts; high, precarious places; toxic or caustic chemicals; high noise areas, and risk of electrical shock.
• A physically able individual is required who can spend time on the floor during activity execution (maintenance, construction, commissioning and qualification).