Metrology Calibration Specialist

Posted 4 Days Ago
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53597, Waunakee, WI, USA
In-Office
Senior level
Pharmaceutical • Manufacturing
The Role
Perform calibration, maintenance, troubleshooting, minor repairs, and documentation for measurement and laboratory equipment in a regulated pharmaceutical manufacturing environment. Maintain traceable standards and calibration records in CMMS/CMIS, coordinate calibration services, support audits and corrective actions, and ensure compliance with cGMP, FDA requirements, and company procedures. Collaborate with Quality, Manufacturing, Engineering, and Facilities while supporting equipment qualification and continuous improvement.
Summary Generated by Built In
Position Summary

Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee!  SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally.  For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs).  SPL has an exciting opportunity to join the team as a Metrology Calibration Specialist.

The Metrology Calibration Specialist is responsible for the calibration, maintenance, troubleshooting, and documentation of test and measurement equipment used in a regulated pharmaceutical manufacturing environment. This role supports equipment reliability and compliance by performing calibration activities, maintaining accurate records, and assisting with quality and regulatory requirements.

This position is open to candidates with a range of relevant experience levels. Candidates meeting the minimum qualifications are encouraged to apply. Final job level and compensation will be determined based on the selected candidate’s education, experience, skills, and overall qualifications.

Key Responsibilities
  • Perform calibration, maintenance, troubleshooting, and minor repairs on test, measurement, and diagnostic equipment (TMDE).
  • Calibrate a variety of instruments including temperature, pressure, electrical, flow, mass, pH, dimensional, and analytical equipment.
  • Support calibration activities for equipment such as recorders, controllers, transducers, moisture analyzers, gas sensors, autoclaves, bioreactors, and laboratory instrumentation.
  • Maintain calibration standards and reference equipment in accordance with established procedures and traceability requirements.
  • Accurately document calibration results and maintain calibration records within the Calibration Management Information System (CMMS/CMIS).
  • Assist in coordinating internal and external calibration services to ensure equipment is calibrated on schedule.
  • Follow approved calibration procedures and support updates to calibration documentation as directed.
  • Participate in routine equipment inspections and help identify opportunities to improve calibration processes and equipment reliability.
  • Support investigations, corrective actions, and internal audits related to calibration activities as needed.
  • Ensure calibration activities are performed in compliance with cGMP requirements, FDA regulations, company procedures, and applicable industry standards.
  • Collaborate with Quality, Manufacturing, Engineering, and Facilities teams to resolve routine equipment and measurement-related issues.
  • Assist with the selection and qualification of measurement equipment for new or modified processes.
  • Contribute to continuous improvement initiatives focused on reducing equipment downtime and improving workflow efficiency.
QualificationsRequired:
  • Associate degree in Electronics, Engineering Technology, Instrumentation Technology, or a related technical field.
  • Minimum of 5 years of calibration and instrumentation experience in a pharmaceutical, biotechnology, medical device, or other regulated manufacturing environment.
  • Working knowledge of cGMP regulations and FDA requirements.
  • Experience calibrating a broad range of instrumentation including temperature, pressure, electrical, flow, and analytical equipment.
  • Experience with computerized calibration management systems (CMMS/CMIS).
  • Strong troubleshooting, documentation, and organizational skills.
Preferred:
  • Bachelor's degree in Engineering or related technical discipline.
  • ASQ Certified Calibration Technician (CCT) certification or willingness to obtain certification.
  • Experience working with external calibration vendors and service providers.
  • Knowledge of NIST traceability principles and calibration best practices.

 

WHY JOIN SPL?

Our employees are our success!  We recruit motivated people, recognize their contributions, and support their development to reach their full potential. 

Perks include: competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more!

SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.

Skills Required

  • Associate degree in Electronics, Engineering Technology, Instrumentation Technology, or a related technical field
  • At least 5 years of calibration and instrumentation experience in a pharmaceutical, biotechnology, medical device, or other regulated manufacturing environment
  • Working knowledge of cGMP regulations and FDA requirements
  • Experience calibrating temperature, pressure, electrical, flow, and analytical instrumentation
  • Experience with computerized calibration management systems such as CMMS or CMIS
  • Strong troubleshooting, documentation, and organizational skills
  • Bachelor's degree in Engineering or a related technical discipline
  • ASQ Certified Calibration Technician certification or willingness to obtain certification
  • Experience working with external calibration vendors and service providers
  • Knowledge of NIST traceability principles and calibration best practices
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The Company
179 Employees
Year Founded: 1976

What We Do

Scientific Protein Laboratories (SPL) is a world leader in biosourced pharmaceuticals, specializing in the development and cGMP-compliant manufacturing of high-quality active pharmaceutical ingredients (APIs). The company is among the largest commercial suppliers of pancreatic enzymes, heparin and its analogs, and other naturally derived products, serving the pharmaceutical, veterinary, and food industries globally.

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