The Facilities Technician III is responsible for executing, maintaining and improving the cGMP equipment, facilities and utility PM Program. This is a key position that ensures the reliability of equipment for Bio-Manufacturing Facility as well as maintaining the current operation of the existing facilities.
- Perform preventative maintenance work on equipment such as steam boilers, HVAC systems, chillers, pumps, pneumatic valves, RO/DI water systems, distillation systems, distribution systems, compressed air systems and other utility systems and equipment supporting manufacturing.
- 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 and engineering change controls 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 to determine the appropriate maintenance information for their processes through the evaluation of equipment specifications.
- Support Regulatory and Internal Audits / Inspections.
- Support 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.
- Assist in the development of investigations and initiation of any documentation resulting from Quality Events with respect to equipment.
- Provide training, coaching and technical direction to lower level Maintenance Technicians.
- 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 facility and utility systems such as: Emergency generators, Fire systems, steam/hot water boilers, vacuum pumps, parts washers, autoclaves, CIP/SIP systems, Incubators, Analytical equipment, and Process tanks, laboratory equipment/systems, as well as facility construction/civil work.
- Strong written, verbal and interpersonal communications skills.
- Strong analytical and problem solving skills and experience applying these skills to resolve technical problems.
- Strong skills and experience in MS Office products (Word, Excel, Outlook, PowerPoint).
- Computer literate in a CMMS (Computerized Maintenance Management Software) such as Blue Mountain or similar computer based maintenance program desirable.
- Demonstrated ability to works on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine recommendations to management.
- Knowledgeable of Electrical, Mechanical, Control/SCADA, PLCs, Process Improvement Methodologies, Root Cause Analysis (RCA), Biotechnology, Pharmaceutical, Utilities Process and construction and facility repairs.
- In-depth knowledge of documentation requirements for cGMP manufacturing.
- Demonstrated good interpersonal skills, customer focus, and professionalism.
- Ability to read, interpret, and troubleshoot engineering drawings, P&IDs, and electrical schematics with assistance when needed.
- Ability to work quickly and effectively without constant supervision.
- Ability to work in a fast-paced environment.
- Ability to work in prolonged sitting, standing, walking, bending, stooping and stretching.
- Ability to climb ladders and stairs of various heights.
- Ability to be exposed to wet or humid conditions.
- Ability to be exposed to outdoor weather conditions.
- Ability to be exposed to noisy environments.
- Ability to regularly lift and/or move up to 45 pounds and occasionally lift and/or move up to 70 pounds briefly.
EDUCATION / EXPERIENCE:
- High School Diploma with a minimum of 10 years in overall maintenance activities of which at least 7 years must be in a cGMP or other FDA regulated operation or a bio-tech facility is required.
- Experience with Start-Up & Commissioning of cGMP Facility.