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Calibration Technician I-Senior

2 months ago

Boulder, United States AGC Biologics Full time
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.

SUMMARY:

The Calibration Technician I - Senior is responsible for maintaining and improving the cGMP Calibration. This is a key position in the readiness of the instrumentation and equipment for the new Bio-Manufacturing Facility as well as maintaining the current operation of the existing facilities.

PRINCIPAL RESPONSIBILITIES:
  • 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.
  • Create, develop and update instrument work plan templates (WPTs). Establish, maximize and improve calibration process tolerances for site instrumentation while maintaining data integrity and measurement traceability for the Calibration Program.
  • 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.
  • Collaborate with manufacturing, quality and operations to understand issues, opportunities for improvements, and partner with them to drive optimization of programs.
  • Assist in qualification activities related to Instrumentation and Process improvement projects.
  • Assist with Off-site Calibration Activities, communicating with Vendors to get calibration quotes and purchase orders etc., and Interface with calibration contractors, ensuring work is compliant with AGC SOP's and cGMP's within the facility.
  • Assist in the development of investigations and initiation of any documentation resulting from 'Out of Tolerance' conditions with respect to instrumentation.
  • As a Senior Technician, may be required to provide training, coaching and technical direction to lower level Calibration Technicians.
  • Ensure compliance with all applicable regulatory agencies including FDA, OSHA, CFR, etc.
  • Plan sequence of testing and calibration procedures for instruments and equipment.
  • Assist in Regulatory and Internal Audits / Inspections.
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.
  • 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 strong 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 different shifts if required.
  • 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 noisy environments.
  • Ability to regularly lift and/or move up to 45 pounds and occasionally lift and/or move up to 70 pounds briefly.
  • This position will be required to be available for on call after hours services for minimum of one week per month
EDUCATION/EXPERIENCE:
  • For Level I:
    • High School Diploma
    • Minimum of 0-2 years' experience in industrial calibration or related field or completion of an apprenticeship program or technical training program in industrial calibration or related field.
  • For Level II:
    • High School Diploma or GED required; technical degree preferred
    • 2-4 years combined education and experience in GMP equipment calibration of Biopharmaceutical manufacturing equipment as: Bioreactors, Pumps, Mixers, Clean utilities (WFI, Clean Steam, Clean Compress Air), HVAC and laboratory process equipment used in a GMP manufacturing utility plant.
  • For Level III:
    • AA/AS degree in Calibration Technician, example: ASQ CCT; equivalent trade school associate degree, or former industrial calibration craft background supplemented by night school training.
    • Minimum of 4- 6 years in overall calibration activities of which at least 3 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.
  • For Level IV:
    • AA/AS degree in Calibration Technician, example: ASQ CCT; equivalent trade school associate degree, or former industrial calibration craft background supplemented by night school training.
    • Minimum of 8+ years in overall calibration activities of which at least 5 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.
  • Strong written, verbal, and interpersonal communications skills to include GDP context.
  • Strong analytical and problem-solving skills and experience applying these skills to resolve technical problems.
  • Ability to read, interpret, and troubleshoot engineering drawings, P&IDs, and electrical schematics with assistance when needed.
  • Candidate should have LOTO knowledge and experience in Pneumatic, Hydraulic, Temperature, Mechanical and Electrical.


COMPENSATION RANGE

$25.65 - $55.48 per hour depending on experience

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.