Metrology Engineer

Metrology Engineer

The Metrology Engineer serves as the technical Subject Matter Expert (SME) for all instrumentation related questions, deviations, or enhancements. This role is responsible for managing the instrument database for assigned areas, which includes the addition, removal, and identification of functionally equivalent replacements for production areas, building utilities, laboratories, and assigned projects. The individual works collaboratively to complete assignments and oversees the successful completion of tasks.

Using solid analytical skills, the incumbent must be able to recognize problems of moderate scope and complexity and independently develop potential solutions and courses of action. This individual represents the work group on multi-disciplinary and cross-functional teams and uses established relationships to influence and lead teams and stakeholders with fact-based, business value knowledge.

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

• Instrument Database Management:
• Creates and controls changes of instrument records and works with approvers for timely processing
• Assures accuracy of data
• Defines and creates guidelines for inputs and general content
• Completes review of calibrations in a timely manner
• Identifies areas for data management process improvements which increases efficiency and/or improve quality of data
• Technical Analysis:
• Leads Root Cause Analysis (RCA) efforts for instrumentation
• Leads Risk Management efforts for instrumentation
• Assures collection of proper data to support failure analysis
• Communicates frequently and as needed with deviation investigators and end users
• Evaluates instrument and system costs long-term including analysis of installation/maintenance costs against the cost of possible failures
• Performs instrument life-cycle assessments
• Parts/Instruments Availability:
• Create stock quantities congruent with supporting analysis
• Assist Reliability Engineer with Functional Equivalent efforts for Metrology
• Works with Stores to develop creative and economical alternatives for long lead time items that may affect site operation (i.e., stocking agreements, standardization, etc.)
• Promotes the standardization of site instruments and instrument installation
• General Responsibilities:
• Support the change management system through the completion of action items
• Metrology lead for deviations in area of responsibility
• Support/create corrective and preventive action plans
• Review functional and criticality assessments for new and existing instruments
• Supports/Leads safety initiatives
• Authors SOP's/SWI's as a technical writer.
• Provides technical guidance to instrument techs (requires working in production areas)
• Maintains training as current
• Presents training materials and other instrument-related communications
• Is the main technical (instrument) contact for end users, Quality and Maintenance in his or her area of responsibility
• Attends coordination and shutdown meetings as required with end users and others
• Assists and backs up other instrument engineers
• Support field related activities - 20% (i.e. Deviation GEMBAs, Troubleshooting, instrument walkdowns, and project activities)

Key Roles

• Instrument database management and data integrity
• Root cause analysis and corrective actions for instrumentation failures
• Reliability strategy and processes for instrumentation (FMEA, RCA, CAPAs)
• Identification and prioritization of instrument-related CI initiatives
• Technical guidance for instrument technicians and end users

Basic Qualifications

Education and experience:

• BS in Engineering Life sciences or related degree with 3+ years relevant experience, OR associate's degree with 5+ years of relevant experience, OR High School Diploma with 10+ years of relevant experience. (hands-on work performing calibrations, typically progressing from a Metrology or Calibration Technician role to an engineering or SME level position)

Technical

Skills:

• Good understanding of current Maintenance and Metrology best practices and common issues addressed by Metrology
• Proficiency with CMMS (i.e. Pro Cal), SAP, Indy Soft, data historian programs are a requirement.
• Experience with the specification and calibration of most of the following instruments is preferred: pressure, temperature, weight, flow, conductivity, chlorine, pH, timers and humidity.

Soft Skills:

• Experience developing,…