Calibration Technician Senior
Calibration Technician Senior
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Our purpose is to bring hope to life by enabling lifechanging 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 Calibration Technician Senior is responsible for maintaining and improving the cGMP Calibration Program at AGC Biologics facilities. This is a key position in the readiness of the instrumentation and equipment for new BioManufacturing Facility as well as maintaining the current operation of the existing facilities.
ESSENTIAL JOB DUTIES/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.
Perform troubleshooting installations and repairs of complex instrumentation on production laboratory and facility systems ensuring all systems and devices are calibrated in accordance with manufacturers specifications and AGC Biologics internal SOPs.
Maintain a safe work environment; work in a safe manner following all safety SOPs 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 cGMPs 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 Offsite Calibration Activities communicating with Vendors to get calibration quotes etc. and Interface with calibration contractors ensuring work is compliant with AGC SOPs and cGMPs 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 lowerlevel Calibration Technicians.
Ensure compliance with all applicable regulatory agencies including FDA OSHA CFR etc.
LEADERSHIP SKILLS
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
Demonstrated good interpersonal skills customer focus and professionalism.
Applies understanding of how the team relates to other related areas to improve efficiency of own team
Recognizes performance improvements and conveys feedback constructively
Works across teams effectively
QUALIFICATIONS
Required:
Associates 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.
Experience with StartUp & Commissioning of cGMP Facility.
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).
Knowledgeable of Electrical Mechanical Control/SCADA PLCs Process Improvement Methodologies Root Cause Analysis (RCA) Biotechnology Pharmaceutical Medical Device Utilities Process.
Indepth knowledge of calibration and documentation requirements for cGMP manufacturing.
Ability to read interpret and troubleshoot engineering drawings P&IDs and electrical schematics with assistance when needed.
Preferred:
Computer literate in Blue Mountain or similar computer based maintenance program desirable.
COMPENSATION
$40.35 $55.48/hour
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 sidebyside with our clients and partners every step of the way. We provide worldclass development and manufacture of mammalian and microbialbased 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 cGMPcompliant facilities in Seattle Washington; Boulder and Longmont Colorado; Copenhagen Denmark; Heidelberg Germany; Milan Italy; and Chiba Japan. We currently employ more than 2500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients most complex challenges including specialization in fasttrack projects and rare diseases. AGC Biologics is the partner of choice. To learn more visit.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.
Required Experience:
IC
Employment Type
Full-Time
