Metrologist

Catalent Pharma Solutions•Glen Burnie, MD

1d•$41 - $48•Onsite

About The Position

Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.

Requirements

High School Diploma or General Educational Development (GED).
2 years of Metrology experience.
Experience working in a GMP environment.

Nice To Haves

Calibration or Metrology certification preferred.

Responsibilities

Perform and document calibrations for a wide range of instruments such as temperature, RPM, weight, pH, DO, flow, and pressure in a highly regulated GMP biopharmaceutical setting.
Create and review calibration SOPs.
Work with external vendors.
Ensure timely completion of calibration tasks.
Collaborate with multiple departments to maintain compliance and operational efficiency.
Work closely with facilities and engineering technicians to minimize equipment downtime and expedite calibration schedules.
Collaborate with manufacturing and laboratory personnel to troubleshoot and repair equipment, instrumentation, and control issues.
Coordinate with subcontractors for equipment calibrations, preventive maintenance, and repairs.
Assist in maintaining the calibration and preventive maintenance program in Blue Mountain, including generating SOPs, establishing frequencies, specifying spare parts, and recommending inventory levels.
Work with equipment vendors and purchasing to quote, purchase, and procure equipment parts and instrumentation.
Initiate and complete GMP documentation such as change control, deviations, corrective and preventive actions (CAPAs), and documentation revisions.
Maintain and complete all equipment logbooks and calibration/maintenance records within the CMMS accurately.
Follow all Safety and Quality procedures and practices.
Assist in asset management and the procurement and processing of purchase orders.
Communicate work results effectively through discussions and documentation with input from the supervisor.
Maintain adherence to GMP SOPs for calibration procedures.
Support other departments including engineering, facilities, and validation to achieve company goals and tasks.
Perform other duties as assigned.