This position provides daily supervision and multi-discipline hands-on support for laboratory and cGMP manufacturing functions in an FDA regulated facility. Oversee daily operation and preventative maintenance of facility systems, utility systems, production/laboratory equipment and instrumentation. Monitor building automation, power generation, fire/security and housekeeping services to ensure compliance with FDA requirements.
- Provide daily supervision for utility systems, production and laboratory equipment. This includes troubleshooting and preventative maintenance for HVAC, compressed gases, emergency power generation, and building automation systems to minimize downtime
- Manage personnel and contractors to PM, troubleshoot, and maintain GMP process, laboratory equipment and building
- Ensure all facility corrective and preventive maintenance is performed at the highest standard levels according to company policies and procedures.
- Provide daily oversight to maintenance of laboratory and cGMP production equipment including commissioning, installation, and preventive maintenance.
- After hours on-call support (e.g., alarm response)
- Responsible for ProCal CMMS system and maintenance of PM schedules and procedures
- Maintain and keep facility equipment files current, including work orders, maintenance, and operational manuals for support documentation.
- Maintain, track and operate test equipment.
- Adhere to all applicable SOPs and procedures.
- Assist in development and review/approval of Facilities technical documents including SOPs, CAPAs, Deviations, and Validation documents.
- Provide alarm reporting and trend data to support batch release and investigations.
- Manage ongoing Facilities improvement projects.
- Assist supervisor in maintaining the department’s budgets and schedules, and with ensuring that performance requirements meet corporate objectives.
- Adhere to safety rules and keep work area in a clean and orderly condition.
- Other duties as required.
- Bachelor’s degree with a minimum 4 years of supervisory experience working in facilities operating under cGMP guidelines is required.
- Basic understanding of electrical, mechanical, building monitoring systems.
- Engineering background and/or Siemens/Iconics BMS experience is strongly preferred.
- Ability to use pallet lifts and hand trucks safely.
- Fluent with Windows computer applications that involve entering and retrieving information from files and reports, word and excel software.
- Demonstrated attention to detail.
- Strong organizational skills and the ability to cope with rapidly changing schedules
- Ability and willingness to be regularly, predictably and reliably at work.
Majority of work is physical in nature. Possess physical strength with ability to lift 40 pounds. Stamina required to stand, walk, climb or step-up for long periods of time.
The requirements listed in this job description are representative of the management’s assignment of essential function, with knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Nothing in this herein restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Furthermore, the job description doesn’t constitute a contract of employment and CoImmune Inc. may exercise its employment-at-will at any time.