Job Details

Job ID: ROCGJP00039359
Job Title: Metrology Specialist
Location: Philadelphia, PA (On-site)

• Required: Strong knowledge of FDA 21 CFR Part 11, cGMP, GDP, and relevant industry standards (ISPE GAMP, ISO, USP, ASTM).

Position Summary
We are seeking a skilled Temporary Metrology Resource for a critical 4-month project at our GTIC facility in Philadelphia. The successful candidate will be responsible for developing a comprehensive master instrument list, executing and documenting calibration activities, and ensuring all instrumentation for critical utilities and building systems complies with cGMP and industry standards. This role is vital for supporting our project timeline and maintaining rigorous quality compliance.

Key Responsibilities

• Develop and maintain the facility's master instrument list, entering calibration parameters for all relevant systems including:
• Building Automation Systems (Client), Environmental Monitoring Systems (EMS), Process Control Systems (PCS/Temperature Control Units), Compressed Air, WFI systems, Parts Washers, Autoclaves, Utility Panels, Water Systems, HVAC, and other utilities.
• Schedule and coordinate all calibration activities and vendor service visits in collaboration with Facilities, Engineering, EHS, system owners, and the project team.
• Review calibration certificates and service reports for accuracy and completeness.
• Accurately enter and maintain all calibration data within the SAP Calibration Management System (or equivalent CMMS).
• Organize and maintain audit-ready instrument history files.
• Complete all required GMP, safety, and procedural training in a timely manner.
• Actively participate in project meetings, providing updates on metrology status and deliverables.
• Support inventory management by stocking calibration parts and maintaining an organized Metrology lab.
• Perform other duties as assigned to ensure project success.

Qualifications & Experience
Education: Associate degree in Engineering, Science, or a related technical field, OR equivalent relevant work experience.

Experience:

• Minimum of 3 years of hands-on experience in instrument calibration, maintenance, and metrology within the pharmaceutical, biotechnology, or another FDA-regulated (cGMP) industry.
• Proven experience calibrating instrumentation for pressure, temperature, level, flow, and pH/conductivity.
• Preferred: Direct hands-on experience with utilities and process instrumentation (WFI, HVAC, compressed air, autoclaves, TCUs, environmental monitoring).

Systems & Compliance Knowledge:

• Required: Strong knowledge of FDA 21 CFR Part 11, cGMP, GDP, and relevant industry standards (ISPE GAMP, ISO, USP, ASTM).
• Preferred: Practical experience with a computerized calibration management system (SAP PM, ProCal, Blue Mountain RAM).

Key Competencies

• Exceptional attention to detail and a firm commitment to data integrity.
• Strong organizational and time-management skills, with the ability to manage a high-volume workload against project deadlines.
• Effective communication and coordination skills for working with cross-functional teams and external vendors.
• Proactive, self-motivated, and able to work with minimal supervision.
• Proficiency with Microsoft Office Suite (Excel, Word).