Calibration Specialist

Position Summary:

Responsible for performing calibration, maintenance, troubleshooting, and repair of laboratory, process, and utility instrumentation to ensure accuracy, reliability, and compliance with applicable procedures and regulatory requirements. This role operates with moderate supervision and supports calibration program execution, documentation, and continuous improvement within a cGMP-regulated environment.

Principal Duties and Responsibilities:

• Perform calibration, installation, maintenance, troubleshooting, and repair of laboratory, process, and utility instrumentation in accordance with SOPs and cGMP requirements.
• Execute calibration activities on moderately complex systems with minimal supervision.
• Troubleshoot instrumentation issues to the component level and implement effective corrective actions.
• Accurately document all work performed, including calibration results and maintenance activities, within the CMMS (e.g., Blue Mountain).
• Review calibration certificates for completeness and accuracy; support timely work order closure.
• Maintain calibration records, equipment histories, and support documentation in a complete and audit-ready state.
• Identify and document out-of-tolerance conditions; escalate and support associated investigations as required.
• Support the implementation and maintenance of calibration and metrology systems for facilities, utilities, and process equipment.
• Coordinate with vendors for calibration services, including scheduling support and escorting as needed.
• Collaborate with Maintenance, Engineering, Validation, and Operations to support equipment availability and compliance.
• Assist in determining calibration requirements for new or modified equipment under guidance.
• Ensure calibration records and documentation are readily retrievable to support audits and inspections.
• Identify routine process improvement opportunities and communicate recommendations to senior staff. 
• Support the development and revision of SOPs and work instructions as directed.
• Participate in cross-functional teams and support operational activities as needed.
• Participate in emergency/on-call rotation as required.
• Perform other duties as required.

Qualification Requirements:

• Bachelor’s degree in engineering, science, or related discipline, or equivalent technical experience.
• 3 + years of experience in calibration, metrology, or instrumentation.
• Working knowledge of cGMP requirements and good documentation practices (GDP).
• Demonstrated ability to troubleshoot instrumentation and equipment issues.
• Experience with CMMS or asset management systems (Blue Mountain preferred).
• Proficiency in Microsoft Office applications.
• Familiarity with calibration standards and measurement principles.
• Strong organizational, communication, and teamwork skills.

Preferred:

• PMEL training
• ISA or equivalent instrumentation certification
• Experience supporting laboratories and process equipment in a GMP environment

Working Conditions:

• Ability to work safely with mechanical, electrical, and process equipment.
• Ability to lift, push, and/or move up to 50 lbs, with or without assistance.
• Required to work in a variety of environments including cleanrooms, laboratories, mechanical spaces, and general facility areas.
• Must be able to comply with gowning requirements and work in controlled environments as applicable.
• Ability to stand, walk, bend, and work in confined or technical spaces for extended periods.
• May be required to work at heights, use ladders, and navigate facility infrastructure.
• Use of personal protective equipment (PPE) is required based on tasks and area.
• May require off-hours, weekend, or on-call support to meet operational needs.

Develops hydrogel-based drug delivery systems for treating eye diseases