Job Description
JOB SUMMARY:
This Facilities Maintenance Technical Lead will provide oversight and support for routine calibration and maintenance of manufacturing cleanrooms and lab infrastructure at our facility in Worcester, MA. This individual will work in a cross-functional environment supporting multiple operations delivering on-time service to internal customers.
Responsibilities:
- Act as owner of calibration and maintenance database (BMRAM).
- Responsible for ensuring all calibration and maintenance work performed on time.
- Assist with service contract negotiations with equipment vendors.
- Lead the scheduling of vendors for calibration, preventative maintenance, and validation vendors.
- Supervise visiting calibration, preventative maintenance, and validation vendors.
- Responsible for maintaining proper calibration/maintenance data entry with multiple users.
- Provide technical service and support to all departments.
- Act as owner for assigned equipment issues.
- Ensure equipment and systems are properly serviced to maintain validated state.
- Support the development, review, and approval of calibration and maintenance plans in BMRAM.
- Prepare, revise, and review calibration/maintenance Standard Operating Procedures (SOP).
- Author and/or contribute to deviations/investigations, Corrective/Preventative Action initiatives, Change Control procedures, technical protocols, and logistical planning.
- Support internal customers through review, prioritization, and response to equipment maintenance/repair requests.
- Independently maintain assigned training curriculum for Operations, Facilities and EHS.
- Mentor/train staff and other resources as needed.
- Support additional facility related tasks as assigned.
- Participate in on call schedule.
Required Qualifications:
- Associates Degree in Engineering or equivalent technical discipline
- 4 years experience maintaining facility systems and equipment
- 2+ years experience within a GMP environment preferred
- Experience with calibration & maintenance databases - *BMRAM preferred*
- Experience with metrology preferred
- Work experience in Life Sciences / Pharmaceutical / Medical Devices industries preferred.
- Working knowledge of cGMP requirements / principals including ISPE and FDA guidelines
- Proven ability to work independently managing multiple tasks effectively in a fast-moving, dynamic, small company environment
Reporting to:
Engineering & Facilities Operations Manager
Salary Grade/Level/Family/Range:
Non-exempt
Position Type/Expected Hours of Work:
Full-Time; flexible schedule within core operating hours between 7am – 6pm
Travel:
Travel is not expected for this position.
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