
Accurate Metrology Professional
2 weeks ago
We are seeking a highly skilled Measurement Instrumentation Specialist to join our team. In this role, you will be responsible for ensuring the accuracy and reliability of critical process instruments used in pharmaceutical manufacturing.
This position involves performing scheduled and unscheduled calibrations to ensure compliance with Good Manufacturing Practices (GMP) standards and FDA regulations.
- Key Responsibilities:
- Perform calibration activities on critical instrumentation, including pressure gauges, temperature sensors, pH meters, balances, flow meters, and other devices.
- Ensure all calibration activities meet current Good Manufacturing Practices (cGMP), FDA, and internal SOP requirements.
- Maintain accurate and traceable calibration records, certificates, and documentation in calibration management systems.
- Troubleshoot and coordinate repairs or replacement of out-of-tolerance equipment.
- Support validation activities by ensuring instruments used in process and quality control are within calibration limits.
- Participate in audits (internal, regulatory, client) by presenting calibration records and demonstrating compliance.
- Assist with maintaining calibration SOPs and improving metrology practices.
- Maintain calibration standards traceable to NIST or equivalent national metrology institutes.
- Collaborate with external vendors/contractors for calibration activities.
- Manage Calibration Scheduling with external and internal stakeholders to complete calibration activities as per scheduled and no overdue calibration.
- Collaborate with QA, Engineering, Production, and Lab teams to prioritize calibration needs without disrupting production.
- Education: Associate's diploma in Instrumentation, Electronics, Engineering Technology, or related technical field.
- Experience: 2-5 years of calibration experience in a regulated pharmaceutical, biotech, or GMP manufacturing environment. Troubleshooting experience on various instruments is must.
- Certifications: Training in USP, ISO 17025, and data integrity principles is preferred.
This role offers a competitive salary and benefits package, including opportunities for professional growth and development.
As a Measurement Instrumentation Specialist, you will have the opportunity to work with a talented team of professionals who are passionate about delivering high-quality results.
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