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. 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 Manager, Calibration will lead and direct the calibration department including technician staff and policies that are responsible for performing and documenting National Institute of Standards and Technology (NIST) traceable calibrations of all measuring and test equipment related to facilities, production and analytical processes, which require routine calibration at our Boulder, CO facility. This includes monitoring the quality of staff technicians and developing new calibration methods as required. This is a key position in the readiness of the instrumentation and equipment for new Bio-Manufacturing Facility as well as maintaining the current operation of the existing facilities.
- Management and improvement of the calibration program procedures and practices.
- Calibration technician workload planning per the schedule maintained in the Blue Mountain RAM CMMS system.
- Management of external calibration activities with 3rd party suppliers.
- Performance of the following tasks either directly or by technician staff:
- Perform calibration work on complex instruments such as Temperature, Pressure, Electronic, Flow, Weight, Level, Speed, pH & Conductivity, Laboratory Equipment and other manufacturing and utility system instrumentation.
- 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 calibration work orders and engineering change controls within the allotted time.
- Maintain all calibration 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 Calibration Information for their processes through the evaluation of Instrument specifications.
- Assist in Regulatory and Internal Audits / Inspections.
- Assist in qualification activities related to Instrumentation and Process improvement projects.
- Assist with Off-site Calibration Activities, communicating with Vendors to get calibration quotes, etc., and Interface with calibration contractors, ensuring work is compliant with AGC SOP's and cGMP's within the facility.
- Assist in the review and development of Calibration Department Procedures.
- Assist in the development of investigations and initiation of any documentation resulting from 'Out of Tolerance' conditions with respect to instrumentation.
- Provide training, coaching and technical direction to lower level Calibration Technicians.
- Ensure compliance with all applicable regulatory agencies including FDA, OSHA, CFR, etc.
- Staff development to enhance GMP compliance and to develop technical capabilities.
- All other duties as assigned.
KNOWLEDGE, SKILLS & ABILITIES:
- Strong knowledge of calibration procedures and techniques, including calibration of Temperature, Pressure, Electronic, Flow, Weight, Level, Speed, pH & Conductivity, Laboratory Equipment among other manufacturing and utility system instrumentation such as: Autoclaves, CIP/SIP systems, Incubators, Analytical equipment, and Process tanks as well as other facility instruments. This will include equipment instrumentation and instruments installed in Loops.
- 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 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 calibration and 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.
- Associate degree in Instrumentation or a related discipline with a minimum of 8 years of overall experience in calibration activities, of which at least 5 years must be in a cGMP or other FDA regulated operations.
- Bachelor's degree in a related discipline with a minimum of 5 years in calibrations activities experience of which at least 3 years must be in a cGMP or other FDA regulated operations.
- Minimum of three (3) years in a supervisory or management role for support preferred
- Experience with Start-Up & Commissioning of cGMP Facility a bonus.
$101,300 - $130,700
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.