Manager, Calibration

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

JOB SUMMARY:
The Manager, Calibration leads and directs 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 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.
 

PRINCIPAL RESPONSIBILITIES:

• Manage and improve the calibration program procedures and practices.
• Workload planning for Calibration technician per the schedule maintained in the Blue Mountain RAM CMMS system.
• Manage external calibration activities with 3rd party suppliers.
• Perform 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.
  • Develop staff 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 with appropriate sections of CFR 21, 820.72, ISO 17025 where applicable.
• 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 regularly lift and/or move up to 45 pounds and occasionally lift and/or move up to 70 pounds briefly.
   

EDUCATION/EXPERIENCE:

• Bachelor degree in a related field plus a minimum of 8 years’ experience, including a minimum of 5 years in calibration activities, 2 years of which must be in a cGMP or FDA-regulated option.
• Experience with Start-Up & Commissioning of cGMP Facility a bonus.
• Equivalent education and experience may substitute for stated requirements.
   

COMPENSATION RANGE:
$108,080- $148,610 annually

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. 

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.  Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

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.

Salary : $108,080 - $148,610