Responsibilities
- Perform scheduled calibrations, adjustments, and preventive maintenance on laboratory, process, and facility instrumentation including pressure, temperature, flow, pH, conductivity, balances, HPLC, incubators, autoclaves, and cleanroom monitoring systems.
- Diagnose and resolve complex instrumentation and equipment issues independently to minimize downtime and maintain operational continuity.
- Escalate unresolved, critical, or systemic calibration and instrumentation issues to the Supervisor, CMMS and Calibration Services, providing clear documentation and recommended actions.
- Develop and execute calibration procedures and protocols in compliance with GMP, ISO, and company standards; recommend updates based on technical findings and regulatory changes.
- Document all calibration activities, maintenance, and repairs accurately in CMMS/Calibration Management Systems to ensure traceability and audit readiness.
- Prepare documentation that meets GMP, FDA, and internal quality standards for inspections and audits; identify and correct gaps in compliance records.
- Conduct root cause analysis and implement corrective and preventive actions (CAPA) for calibration-related deviations.
- Identify inefficiencies in calibration and maintenance processes and implement improvements that enhance accuracy, consistency, and productivity.
- Collaborate with process engineers, manufacturing, quality assurance, and facilities teams to resolve technical issues and align on operational priorities.
- Train and guide team members and contractors on calibration procedures, equipment handling, and documentation standards to ensure consistency and compliance.
- Lead technical investigations using structured, data-driven approaches to resolve instrumentation failures and recurring issues.
- Communicate clearly and professionally with internal stakeholders to share updates, findings, and recommendations.
- Prioritize and manage multiple tasks and projects independently in a fast-paced, regulated environment while meeting deadlines and quality expectations.
- Promote a culture of safety, inclusion, and continuous improvement across calibration and maintenance activities.
Work Arrangement
On-site
Additional Information
- Must be able to work in a regulated manufacturing environment, including construction/start-up phases, with appropriate PPE.
- Reasonable accommodation will be provided as required by law.
- Requires up to 5% domestic travel, based on business need.
- This position is designated as essential to site operations, as such the employee may be required to report to the facility or remain on-site during certain operational or emergency situations to ensure business continuity.
- On-call availability may be required to support urgent operational needs.
- Must be able to perform the physical requirements of the role, including occasionally lifting to 50 lbs, with or without reasonable accommodation.
- Regular exposure to machinery, noise, and physical hazards in a manufacturing environment; appropriate personal protective equipment (PPE) is provided and required at all times.
