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 Calibration Technician III/IV is responsible for maintaining and improving the cGMP Calibration Program at AGC Biologics. 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.
- Perform calibration work on instruments such as Temperature, Pressure, Electronic, Flow, Weight, Level, Speed, pH & Conductivity, Laboratory Equipment and other manufacturing and utility system instrumentation.
- 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, in an orderly and accurate manner in compliance with cGMP's by the utilization of the site CMMS and Document Management Systems.
- Assist in Regulatory and Internal Audits / Inspections.
- Assist in qualification activities related to Instrumentation and Process improvement projects.
- Ensure compliance with all applicable regulatory agencies including FDA, OSHA, CFR, etc.
- All other duties as assigned.
KNOWLEDGE, SKILLS & ABILITIES:
- Advanced 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.
- Knowledgeable of Electrical, Mechanical, Control/SCADA, PLCs, Process Improvement Methodologies, Root Cause Analysis (RCA), Biotechnology, Pharmaceutical, Medical Device Utilities Process.
- 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.
- High School or equivalent required; Associate degree in Instrumentation or a related discipline desired.
- 3+ years’ experience in a cGMP or other FDA regulated operations desired.
- Experience with Start-Up & Commissioning of cGMP Facility.
- Position level to be determined based on education and years of experience of candidate.
$56,002 - $81,172
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