Position Summary & Role
The Senior Specialist, Metrology installs, maintains, tests, repairs, and calibrates a wide range of electrical/mechanical equipment in a Good Manufacturing Practices (cGMP) environment and a Good Laboratory Practices (GLP) environment in accordance with environmental, health, safety, and GLP/cGMP guidelines. The Metrology Specialist reports directly to the Associate Director, Facilities Operation & Maintenance or Engineering Director. The Metrology Specialist will initially be heavily focused on establishing the onsite Metrology Lab, and identifying procedures, tools, and training necessary for enhanced site operational readiness.
The Senior Specialist, Metrology will perform instrument calibrations against NIST traceable standards and will document work in accordance with the calibration program procedures and good documentation standards. This role will investigate and troubleshoot instrument failures, support investigations for out of tolerance instruments, and determine when replacement is warranted. Continuous improvement activities include evaluation of market options and internal instrument standardization.
This is an exciting opportunity to be a key technical contributor to the existing GMP manufacturing facility and development labs enabling future build out capabilities of the site.
Leads the implementation and operational readiness of the onsite Metrology Lab and the site Calibration Program.
Coordinates and/or executes calibration for systems and equipment used by the facilities, operations, and development groups. This may include Incubators, Pressure/Vacuum, Differential Pressure, pH, Flow, Temperature/Humidity Transmitters, Analytical Balances/Lab instrumentation/Load Cells, and other environmental and safety systems.
Expert knowledge and application of instruments, equipment, and loop calibrations of various manufacturing, utilities, and laboratory environments.
Monitors and maintains calibration of instruments and equipment. Exceptional Computer Maintenance Management System (CMMS) Skills.
Ensures test equipment for NIST traceability are maintained.
Coordinate and manage daily work load without direction from manager. Excellent communication and problem-solving skills. Teamwork oriented.
Must be able to explain calibration issues and processes to end users when needed.
Performs routine and unscheduled calibrations of various systems and instrumentation located throughout the facility.
Document’s and performs all work in accordance with company policies and standard operating procedures.
Oversees work performed by outside contractors and/or equipment vendors, championing a conscientious attitude toward the quality of work.
Provides input into and reviews Maintenance and Metrology SOPs, job plans, and calibration data sheets.
Performs instrumentation installation, configuration, calibration, and training on calibration methods and procedures to staff members.
Coordinates with MSAT, Engineering, Manufacturing and Analytical Lab teams to understand process and tolerance requirements.
Executes work in accordance with company policies and procedures, including the coordination of activities with a minimal disruption of manufacturing, lab, and facilities operations.
Works with Engineering and Facilities teams providing input to preventative maintenance plans, spare part inventory, CMMS data to achieve consistent and reliable high performing instruments and equipment.
Leads troubleshooting response and resolution identification for instrumentation failures.
Monitors instrument failure rates and lifecycle to determine replacement frequency and/or new instrumentation solutions for application.
Supports EHS and QA initiatives to ensure compliance with all government regulations, site standards, and programs.
Supports technical investigations for Out of Tolerance events, CAPAs, and change controls.
Participates as Metrology Subject Matter Expert (SME) for instrumentation on cross-functional project teams during equipment design, selection, construction, start-up, commissioning, and qualification. Ensure that a consistent Resilience network technical approach for instrumentation is used across projects at the site.
Performs a variety of technical service/support duties to plant operations.
Performs other related duties assigned by management.
Minimum Experience, Education & Qualifications
HS diploma with 6+ years of applicable calibration experience in a cGMP environment, or
Associates degree with 4+ years of applicable calibration experience in a cGMP environment
Technical training or certification in calibration or metrology
Proficient using computers and Microsoft Office Suite
Preferred Experience, Education & Qualifications
Bachelor degree in Electrical engineering, Electronics, Electromechanical engineering, or related discipline.
CCT, CQT, CETma, or ISA certification a plus
Experience programming or installing a distributed control system
Prior experience in the pharmaceutical, biotechnology, or medical device industry.
Previous experience with new facility projects and new process equipment startup.
Experience authoring investigations in a GMP environment
Experience working in a clean-room environment requiring special or aseptic gowning
Electrical troubleshooting experience, working on up to 480VAC, and knowledge of NFPA 70E requirements.
Other Ideal Personal Characteristics:
Strong background in calibration of analytical, process equipment, and utility instrumentation.
Demonstrated familiarity with cGMP manufacturing and regulatory requirements for pharmaceuticals and/or medical devices.
Experience using asset management software and/or calibration management software.
Familiar with technical systems documentation (P&IDs, URS, FS, FAT/SAT, Commissioning, IOQs, SOPs, data sheets, material and equipment specifications, safety data sheets, etc.)
Demonstrated ability to troubleshoot, solve problems, synthesize data, summarize outcomes, and provide recommendations on a compliant path forward.
Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across corporate functions and multiple stakeholders.
Proficient using computers & software programs such as MS Word, Excel, Outlook, etc.
Excellent interpersonal, communication and presentation skills.
Ability to manage multiple priorities at one time and adjust priorities as necessary.
Ability to manage both day-to-day operations as well as project work in a fast-paced environment.
Physical Demands and Work Environment:
Must have the ability to lift up to 50 pounds.
Requires physical activity such as standing for long periods of time, walking, and working with hands.
Must be able to work in a controlled or clean room environment requiring special gowning.
Must have the ability to work safely and conscientiously in a manufacturing environment.
Some evening support, weekends or holiday coverage may be required.
This position may require occasional travel to vendor locations. Average travel for this position is expected to be less than 5%
Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $95,000.00 - $117,500.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.