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Facilities Mechanic

GENERAL DESCRIPTION/FUNCTION:

This role is responsible for supporting the overall facilities operation in this GMP manufacturer of Phase I/II bulk biologics.  Lifting up to 40 lbs., and work on ladders/step stools required.  Shift work and/or weekend work may be required at times.

Duties & Responsibilities:

Operates and maintains utility systems – HVAC, clean steam generator, chiller, usp-water/DI water skids, plant steam boilers, air compressors
Assists management writing operational protocol(s) and preventive maintenance and calibration
Accurately completes/maintains all equipment logbooks and maintenance records
Routinely troubleshoots/repairs laboratory and manufacturing equipment such as:

Fermenters, pumps, filtration skids, freezers, etc.

Participates in facility expansion, validation
Recommends parts/supply purchases for equipment within the manufacturing/lab areas
Works closely with manufacturing/lab staff to troubleshoot and repair equipment problems
Works under general supervision to meet project goals
Works closely with various departments and offers assistance as needed
Follows safety procedures, practices and cGMPs

Skills & Technical Expertise:

Has basic understanding of mechanical and electrical systems in a biopharmaceutical manufacturing/R&D facility, supporting the GMP production of Phase I/II bulk Biologics
Has basic math and computer skills (WORD, EXCEL) and must be familiar with building automation systems (BAS)
Must obtain Grade 3 Stationary Engineer’s License within the first year of service
Good mechanical ability for equipment troubleshooting and repair
Experience in working in an FDA regulated, cleanroom environment that requires full gowning (Tyvek coverall, gloves, hair cover, shoe covers)
Must be able to clearly communicate in English (verbally and written)

Supervision:

Works under general supervision on day-to-day activities and accomplished tasks

Measurement of Performance:

Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors
Timeliness and accuracy in completion of projects and paperwork (quantity of work)
Contributions to projects beyond general responsibilities (quality of work)
Identification of problem areas affecting operations (knowledge/problem solving)
Offers suggestions for correcting problems and for improving operations
Exercises good judgment in dealing with operational problems
Understanding of theory, rationale behind tasks performed
Demonstrated understanding and adherence to policies, safety procedures and the cGMPs
Ability to succeed in a team-oriented environment under very dynamic conditions

Education & Previous Experience:

High School Diploma
3+ years’ related experience (hospital, food, chemicals, biologics manufacturing, maintenance)

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