Senior Calibration and Metrology Lead

Bora Pharmaceuticals; Rockville (MD); On-site; USD 155,000 - 175,000; Full time

Benefits offered by this job

Health coverage

Retirement plan

Paid time off

Professional development

Wellness resources

Job summary

Bora Biologics is seeking a Senior Manager, Metrology to lead the site calibration and metrology program at Bora Biologics, ensuring compliant, reliable, and efficient calibration activities for manufacturing equipment, lab instrumentation, and utilities.

You will own BMRAM data integrity, oversee staff, coordinate maintenance, and drive continuous improvement while collaborating with Facilities, Quality, Manufacturing, and IT to meet cGMP and regulatory requirements.

Qualifications

• Requires a minimum of 12 years of progressively responsible metrology/calibration experience in a regulated environment, with at least 2 years of supervisory experience.
• Demonstrated knowledge of cGMP requirements and calibration/metrology principles.
• Strong knowledge of ISO, ISPE guidance, CFR requirements and calibration standards.
• Experience developing and managing calibration schedules, priorities, and compliance metrics.

Responsibilities

• Lead site calibration program; establish standards, procedures, and best practices in line with cGMP and quality requirements.
• Coach and mentor calibration staff; manage workload and training to meet productivity goals.
• Own BMRAM system data integrity and calibration records management; handle OOTs and approvals.

Skills

Metrology leadership

Calibration management

Cross-functional leadership

Strong communication

Problem solving

Education

Bachelor's degree in Engineering

High School Diploma + 12+ years experience

Tools

BMRAM

MS Office

Job description

Bora Biologics is seeking a Senior Manager, Metrology to lead the site calibration and metrology program at Bora Biologics, ensuring compliant, reliable, and efficient calibration activities for manufacturing equipment, lab instrumentation, and utilities.

You will own BMRAM data integrity, oversee staff, coordinate maintenance, and drive continuous improvement while collaborating with Facilities, Quality, Manufacturing, and IT to meet cGMP and regulatory requirements.