About Us
With an extensive offering of development services, state-of-the-art manufacturing equipment, and project support, we are truly a full-service CDMO biologics partner. Our approach pairs our expert knowledge base with an open mind towards scientific discovery so that together we can develop an optimal way to make our systems work for you and your biologics project, no matter how complex it may be.
Scope of Function:
The Maintenance Technician II maintains and repairs equipment, systems, and facilities within a regulated environment to ensure compliance with Good Manufacturing Practices (GMP). Key responsibilities include performing preventive maintenance, troubleshooting mechanical, electrical, and HVAC issues, meticulously documenting activities, adhering to safety and hygiene protocols, and collaborating with Quality and Operations teams to guarantee the safety, quality, and efficacy of products.
Key Responsibilities:
- Conduct daily facility walk-throughs to verify the operational condition of critical areas and equipment.
- Undertake PMs in accordance with the monthly PM plan for facilities, equipment, HVAC, and utility systems.
- Undertake unplanned maintenance in accordance with issued work orders for equipment and utility systems.
- Manage external contractor(s) to undertake unplanned maintenance in accordance with issued work orders for equipment, utility, and HVAC systems (where work cannot be undertaken in house).
- Ensure materials, consumables and spare parts are prepared in advance to allow PMs to be undertaken in accordance with the monthly PM plan and the annual shutdown plan.
- Ensure all documentation (including but not limited to PM, annual shutdown, work order, and investigations) is complete in a timely manner and uploaded to our Quality Management System (QMS) in accordance with the requirements.
- Upload documentation, populate relevant fields and close activities in our Quality Management System (QMS).
- Assist in equipment, utility, and HVAC system investigations / corrective actions and ensure completion of documentation in accordance with the requirements of the Quality Management System.
- Maintain training in accordance with the Quality Management System.
- Ensure all mechanical spaces, mezzanines and ceiling spaces are appropriately finished, dust free, neat, and organized with no unauthorized / improper storage of equipment, materials, consumables and / or spare parts.
- Support facility construction activities.
- Work as a member of the emergency response team addressing equipment malfunctions, alarms generated by the environmental monitoring system and assisting in hurricane readiness activities.
- Ability to lift up to 55Lbs.
- Other duties as assigned.
The ideal candidate will have:
- Associate Degree in Engineering.
- A minimum of five (3) years of experience in GMP Pharmaceutical/Biotech environment required.
- Must have experience working in a cleanroom environment
- Sufficient computer skills including experience with a Quality Management System (QMS) and Computerized Maintenance Management System (CMMS)
- Good mechanical, hands-on, and excellent documentation skills.
- Experienced with various Control Systems (BAS/BMS, PLC, HMI)
- Experience with Rees system
- Technical certification (EPA 608 or other HVAC certifications or CEST or CMRT or NCCER)
Interacts with: All departments
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