Job Summary:

The Calibration Technician supports pharmaceutical manufacturing by performing scheduled and unscheduled calibrations of critical process instruments, ensuring equipment complies with GMP standards and FDA regulations. This role ensures all measurement devices remain accurate, reliable, and compliant with industry standards such as ISO 17025, USP , and .

Key Responsibilities:

• Calibrate, inspect, and verify critical instrumentation used in pharmaceutical manufacturing, utilities, and laboratory environments (e.g., pressure gauges, temperature sensors, pH meters, balances, flow meters, etc.).
• 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 (e.g., CMMS, SAP).
• 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 of vendors / contractors for calibration activities (e.g SIC, Permit To Work).
• Able to 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.
• Assist on any ah-hoc duties that have been assigned / task by the immediate superior.

Qualifications:

• 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 like pressure transmitters, temperature, relative humidity sensors etc. is must.
• Certifications (preferred):
  • Training in USP , , and practices

Skills:

• Strong understanding of GMP, FDA 21 CFR Part 11, and data integrity principles.
• Familiarity with calibration software such as SAP etc.
• Working knowledge of risk-based instrument classification.
• Excellent documentation and problem-solving skills.

Physical & Work Environment Requirements:

• Ability to work in cleanroom, lab, and utility areas following gowning and safety protocols.
• Able to lift up to 25 lbs and work on ladders, if needed.
• Occasional weekend or off-shift support may be required.