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 manuf…
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Full-time
associate degree, bachelor degree
Posted 27d ago
Apply by Oct 8
~40 hrs/week
Responsibilities
The Metrologist provides calibration and instrumentation oversight for laboratory and facility equipment across GMP manufacturing and R&D sites. Responsibilities include performing corrective and preventative maintenance, managing documentation, and ensuring equipment remains fit-for-purpose.
Requirements
Requires a B.S. in science/engineering with 2-5 years of GMP pharmaceutical experience, or an associate's degree with 5+ years of experience. Candidates must have technical ability to troubleshoot pharmaceutical equipment like HPLCs and stability chambers.
Full job 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 and non-GMP research laboratories
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
Work Environment:Climate controlled office and laboratory.
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.
Topical & Transepithelial CDMO | From Concept to Commercialization
Industry
Pharmaceutical Manufacturing
Company size
51-200 employees
Founded
1999
Headquarters
Durham, North Carolina
LinkedIn followers
22,073
MedPharm is a specialized CDMO focused on the development, testing, and manufacture of topical and transepithelial drug products.
We partner with pharmaceutical and biotechnology companies to advance innovative therapies from early development through clinical and commercial manufacturing. Our integrated capabilities span formulation development, analytical and bioanalytical testing, research biology, IVRT and IVPT studies, clinical trial material manufacturing, scale-up, and commercial manufacturing.
With expertise across multiple routes of delivery, including skin, nail, eye, respiratory (nasal and lung), and mucosal applications, MedPharm helps sponsors overcome complex development challenges and generate the data needed to make confident decisions throughout the product lifecycle.
Backed by more than 25 years of experience, specialized research models, and deep regulatory expertise, we combine scientific insight with practical execution to help accelerate development and support successful commercialization.
From concept to commercialization, MedPharm helps transform promising drug products into patient-ready therapies.
Offices: 4018 Stirrup Creek Dr, Durham, North Carolina 27703, US · Surrey Research Park, Unit 3, Guildford, Surrey GU2 7AB, GB · 4222 Emperor Blvd, Suite 335, Durham, North Carolina 27703, US
Topical Drug DevelopmentTransdermal Drug DevelopmentMucosal Drug DevelopmentTopical and Transdermal Formulation DevelopmentClinical Trial ManufacturingCommercial ManufacturingGMP Clinical Trial SupplySemi-Solid ManufacturingIVRTIVPT
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