Job Description

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.

Qualifications

Required:

• 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.

You should be proficient in:

• Continuous Improvement
• Troubleshooting Skills
• FDA Regulations
• Pharmaceuticals
• Standard Operating Procedures (SOPs)
• Precision Measurement & Hand Metrology
• Good Manufacturing Practices (GMP)
• Precision Measurement & Inspection

Machines & technologies you'll use:

• Coordinate Measuring Machine (CMM)
• CMIS