Metrologist

MedPharm Position Description

Job Purpose: This position contributes to company success by providing calibration and instrumentation oversight for laboratory and facility equipment across MedPharm's Durham sites, including the Stirrup Creek GMP manufacturing facility and the Emperor Boulevard R&D laboratories. The role executes scheduled calibrations and preventative / corrective maintenance in compliance with GMP regulations, internal procedures, and research laboratory requirements, ensuring equipment is maintained in a state of control and fitness for intended use across both regulated and non-GMP environments.

Summary of Key Responsibilities:

• Maintain and perform corrective, preventative maintenance calibrations on GMP and non-GMP equipment
• Performs maintenance, testing, troubleshooting, calibration, and repair of electrical circuits, components, analytical instruments, and pharmaceutical laboratory and manufacturing equipment.
• Maintains all logs and required documentation.
• Writes Out-Of-Tolerances (OOT's) and Deviations.
• Disassembles and reassembles instruments and equipment, using hand tools, and inspects instruments and equipment for defects.
• Entering and updating CMMS system information relevant to calibrations performed
• Provide recommendations for instrumentation / metrology spare parts and PM procedures
• Work closely with Validations and Stability Manager, Lab Operations, R&D scientific teams (Emperor Boulevard, Manufacturing and Quality to ensure strict compliance with GMP guidelines, specifically to ensure to ensure instrumentation remains compliant and fit-for-purpose across both GMP and non-GMP operations
• Support calibration, maintenance, and troubleshooting of instrumentation across both GMP and R&D environments, including bioanalytical, research biology, and in vitro testing at the Emperor Boulevard R&D site.
• Ensure instrumentation readiness, uptime, and compliance across two distinct operational environments: GMP-regulated manufacturing (Stirrup Creek) and non-GMP research laboratories (Emperor Boulevard).
• Assist in the maintenance and review of calibration standards and vendor calibration documentation
• Work with contract service providers and support contractors executing calibration and metrology activities
• Provide support to other departments to troubleshoot, test, repair and optimize instruments, equipment and control systems
• Provide support for IQ/OQ and PQ of new systems throughout the facility

Required Qualifications and Skills:

• B.S., in a scientific or engineering discipline, with 2-5 years of relevant GMP pharmaceutical experience, or an Associate's Degree in a relevant technical discipline with 5+ years of GMP pharmaceutical or equivalent
• Knowledge of current industry expectations of validation requirements for equipment validation and qualification
• Technical ability to problem solve and troubleshoot equipment systems in a pharmaceutical environment, including but not limited to: HPLCs, balances, pH meters, HVAC, chart recorders and stability chambers
• Flexibility to work outside of business hours, should issues arise
• Knowledge of Quality systems
• Speaks, writes, listens and presents information in a logical and articulate manner appropriate for the audience
• Able to multi-task productively, well organized, effectively applies time management processes and procedures
• Ability to recognize what needs to be done, taking action, and accomplishing results as the situation demands

Supervisory Responsibility:

Direct Reports: None

Indirect Reports: None

Confidential Data: Yes

Travel Requirements: Limited local travel between Durham sites (Stirrup Creek and Emperor Boulevard)

PHYSICAL DEMAND ANALYSIS

DESCRIBE WORK ENVIRONMENT: Climate controlled office or laboratory environment.

SUMMARIZE THE PHYSICAL DEMANDS ASSOCIATED WITH THIS POSITION: The physical demands are minimal.

PHYSICAL DEMANDS OF ESSENTIAL FUNCTIONS:

X IN APPROPRIATE COLUMN:

O = OCCASIONAL F = FREQUENT C = CONSTANT

WEIGHT INVOLVED (IF APPLICABLE)

FREQUENCY OF ACTION - UNDER 20 LBS - 20-60 LBS - OVER 60 LBS

O - F - C - O - F - C - O - F - C - O - F - C

STANDING - X

WALKING - X

SITTING - X

CARRYING - X

BENDING - X

LIFTING - X

PUSHING - X

PULLING - X

TWISTING - X

REACHING - X

SEEING - X

GRIPPING - X

HEARING - X

Scale - OCCASIONAL 1-33% OF TIME FREQUENT 34-66% OF TIME CONSTANT 67-100% OF TIME

All position requirements listed indicate the minimum level of knowledge, skills and/or experience necessary to perform the job proficiently. This position description is not to be construed as an exhaustive statement of duties, responsibilities or requirements. Employees will be required to perform any other job-related duties as requested by their supervisor, subject to reasonable accommodation.