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.
The Maintenance Technician IV/Lead Maintenance Technician is responsible for executing, maintaining and improving the cGMP equipment PM Program at AGC Biologics facilities in Bothell, WA. 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.
- 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 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 determine the appropriate maintenance information for their processes through the evaluation of equipment specifications.
- Assist in Regulatory and Internal Audits/Inspections.
- 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.
- 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 manufacturing and utility systems such as: 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 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, Medical Device Utilities Process.
- 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.
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.