Metrologist

Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus features two manufacturing facilities and is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. It is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 facility is EMA and FDA approved, spans approximately 200,000 sq. ft., and 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.

About the role

We have an opportunity for a Metrologist to join our team and support the execution of calibrations in a dynamic environment. You will 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. This role involves creating and reviewing calibration SOPs, working with external vendors, and ensuring timely completion of calibration tasks. You will collaborate with multiple departments to maintain compliance and operational efficiency.

Responsibilities

• 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.

Requirements

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

Preferred Qualifications

• Calibration or Metrology certification preferred.

Pay

The anticipated hourly rate for this position in MD is $40.86 – $48.07 plus bonus. The final hourly rate offered to a successful candidate may vary and will be dependent on several factors including, but not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, and business needs.

Schedule

Monday - Friday, 8am-4:30pm

100% Onsite

Benefits

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• Competitive paid time off plus 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition Reimbursement.