Requires a good understanding of mechanical and electrical systems in a biopharmaceutical manufacturing/R&D facility, supporting the GMP production of Phase I/II bulk biologics.
Mature professional capable of working with minimal supervision.
Requires basic math and computer skills (WORD, EXCEL) and must be familiar with building automation systems (BAS).
Must have the ability to lift/carry 40 lbs and to work on ladders/step stools.
Requires working extended periods on his/her feet in a fast-paced environment.
Installs/ reconfigures lab and utility equipment to accomplish company goals.
Requires automation and controls engineering design, repairs and maintenance
Shift work and/or weekend work will be required at times.
Will be working in an FDA regulated, cleanroom environment that requires full gowning (tyvek coverall, gloves, hair cover, shoe covers.)
Duties & Responsibilities:
Will operate and maintain utility systems – HVAC, clean steam generator, chiller, usp-water/DI water skids, plant steam boilers, air compressors, house vacuum, and refrigeration systems.
Mechanical/ Electrical troubleshooting skills are essential.
Will assist in establishing/maintaining calibration and preventative programs for the facility; this includes generating operational protocol(s) and preventative maintenance SOPs/records for various utility systems and equipment (manufacturing/lab).
Ensure BAS operations for the facility are functional.
Works with staff and subcontractors on equipment preventative maintenance and calibration.
Accurately maintains/completes all equipment logbooks and maintenance records within a software maintenance management program.
Senior repair technician of laboratory and manufacturing equipment such as: fermenters, chromatography skid/ HPLC systems, pumps, filtration skids, freezers, centrifuges etc.
Will participate in facility expansion, validation.
Works under general supervision to meet project goals.
Will recommend parts/supply purchases for equipment within the manufacturing/lab areas.
Works closely with manufacturing/lab staff to troubleshoot and repair equipment problems.
Works closely with various departments and offers assistance as needed.
Must follow safety procedures, practices and the cGMPs.
Skills & Technical Expertise:
High School Diploma (Minimum)
> 8 years related work experience (GMP / Bio-Pharma maintenance/ engineering)
Class III Stationary Engineer’s license is preferred
Demonstrated abilities in mechanical/electrical design, repairs and maintenance.
Must have proficient knowledge of controls and automation operations
Must be able to clearly communicate in English (verbally, written).
Minimum supervision required on day-to-day activities and accomplished tasks
Supervisory input focused on status and future of project or technical area and long-term development path
Measurement of Performance:
Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to a project team
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