Maintenance Technician I-Senior (NIGHT SHIFT)

AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.

 

SUMMARY:

The Maintenance Tech I/II is a skilled multi-craftsperson responsible for performing advanced installation, troubleshooting, maintenance, repair, testing, and documentation/logs of a wide variety of manufacturing production equipment and process utilities. The Mechanic will also provide maintenance and support to GMP Facilities and utility systems.

The Maintenance Technician II/III is responsible for executing, maintaining and improving the cGMP equipment PM Program at AGC Biologics facilities. This is a key position that ensures the reliability of equipment for new Bio-Manufacturing Facility as well as maintaining the current operation of the existing facilities.

The Maintenance Technician III/IV is responsible for executing, maintaining and improving the cGMP equipment PM Program at AGC Biologics facilities in Boulder, CO. This is a key position that ensures the reliability of equipment for new Bio-Manufacturing Facility as well as maintaining the current operation of the existing facilities.

All work must be completed with minimal impact to production while complying with cGMP, when appropriate, and AGC regulations. May perform general labor duties as needed and work outside of core business hours upon short notice.

This role is a night shift position. Hours are 6 pm to 6:30 am

The shift is a 2 2 3 schedule

Week 1:

Off: Monday Tuesday

Work: Wednesday Thursday

Off: Friday Saturday Sunday

 Week2:

Work: Monday Tuesday

Off: Wednesday Thursday

Work: Friday Saturday Sunday

Repeats each week

 

PRINCIPAL RESPONSIBILITIES:

• Perform preventative maintenance work on complex manufacturing equipment such as bioreactors, processing pumps, valves, RO/DI water systems, distillation systems, distribution systems, steam generation, compressed air systems and other manufacturing and utility system equipment.
• Perform troubleshooting, installations and repairs of complex instrumentation on production, laboratory and facility systems, ensuring all systems and devices are calibrated in accordance with manufacturer's specifications and AGC Biologics internal SOP's.
• Maintain a safe work environment; work in a safe manner following all safety SOP's and wear Personal Protective Equipment as required.
• Maintain assigned area of ownership within the facility to support inspection readiness and general facility upkeep for support of clinical and commercial manufacturing.
• Complete maintenance work orders within the allotted time.
• Maintain all assigned maintenance records, work orders, and investigations in an orderly and accurate manner in compliance with cGMP's by the utilization of the site CMMS and Document Management Systems.
• Assist Equipment Owners determine the appropriate maintenance information for their processes through the evaluation of equipment specifications.
• Assist in qualification activities related to Instrumentation and Process improvement projects.
• Assist with Vendors to get maintenance quotes, etc., and Interface with maintenance contractors, ensuring work is compliant with AGC SOP's and cGMP's within the facility.
• Assist in the review and development of Maintenance Department Procedures.
• Ensure compliance with all applicable regulatory agencies including FDA, OSHA, CFR, etc.
• All other duties as assigned.

 

KNOWLEDGE, SKILLS & ABILITIES:

• Strong knowledge of maintenance procedures and techniques related to manufacturing and utility systems, that may include Autoclaves, CIP/SIP systems, Incubators, Analytical equipment, and Process tanks as well as other facility equipment.
• Strong written, verbal and interpersonal communications skills.
• Strong analytical and problem solving skills and experience applying these skills to