Senior Metrology or Calibration Engineer (Contract)
In addition to the assessment, the candidate will provide technical support for equipment decommissioning, installation, calibration, and integration of critical laboratory and manufacturing equipment into the site's metrology program. Key Responsibilities
- Perform a comprehensive assessment of the site's Metrology Program.
- Review and validate approximately 600 metrology assets, including laboratory instruments, timers, thermometers, balances, gauges, pressure and temperature devices, and other calibrated equipment.
- Evaluate calibration records, maintenance history, asset identification, calibration intervals, traceability, and documentation for compliance with GMP and internal procedures.
- Assess metrology program effectiveness, identify gaps, and recommend corrective and preventive actions (CAPAs).
- Evaluate known instrument performance risks and recommend improvements to increase equipment reliability and audit readiness.
- Support equipment decommissioning activities, ensuring proper documentation, asset disposition, and quality system compliance.
- Provide technical oversight for installation, calibration, and commissioning support of critical laboratory and process equipment.
- Review calibration procedures and recommend improvements where appropriate.
- Verify traceability to NIST (or equivalent national standards), uncertainty considerations, and calibration best practices.
- Prepare detailed assessment reports, observations, risk assessments, and executive summaries.
- Collaborate with Quality Assurance, Engineering, Validation, Manufacturing, and Laboratory personnel to resolve metrology issues.
- Support regulatory inspection readiness and internal audit preparation.
- Bachelor's or Associate (certification) degree in Engineering, Physics, Metrology, Instrumentation, Engineering Technology, or a related scientific discipline.
- Minimum 7 years of metrology, calibration, or instrumentation experience in FDA-regulated pharmaceutical, biotechnology, medical device, or life sciences industries.
- Extensive knowledge of GMP requirements and calibration program management.
- Strong understanding of FDA 21 CFR Parts 210, 211, and 820 (QMSR), ISO 13485, ISO/IEC 17025, and applicable industry standards.
- Experience assessing large calibration programs involving hundreds of assets.
- Plus if experience with computerized calibration management systems (e.g., Blue Mountain RAM, Beamex CMX, IndySoft, GAGEtrak, Maximo, SAP PM, or equivalent).
- Strong understanding of calibration uncertainty, traceability, and measurement science.
- Excellent technical writing, documentation, and communication skills.
- ASQ Certified Calibration Technician (CCT) or equivalent certification.
- Experience supporting FDA inspections and regulatory audits.
- Experience performing gap assessments and remediation projects.
- Familiarity with commissioning, qualification (IQ/OQ/PQ), and equipment lifecycle management.
- Experience with laboratory and manufacturing instrumentation in pharmaceutical or medical device facilities.
- Comprehensive QC Metrology Program Assessment Report.
- Asset-by-asset validation summary and compliance review.
- Gap assessment with risk ranking and recommended corrective actions.
- Equipment decommissioning documentation support.
- Installation and calibration support for critical equipment.
- Executive summary with prioritized recommendations to improve compliance, reliability, and audit readiness.
- Strong analytical and problem-solving abilities.
- Excellent organizational and project management skills.
- Ability to work independently with minimal supervision.
- Strong interpersonal skills with the ability to communicate effectively with cross-functional teams and client stakeholders.
- Ability to prioritize multiple tasks while meeting aggressive project timelines.
Recommended Jobs
MO616- Microsoft Power Platform and Power BI Developer 11697-1-W2 only, no Subs allowed.
Job Description Job Description T W2 only, no Subs or corp to corps allowed. This job is remote; you may have to come on site from time to time for meetings in Columbia, SC. The c…
Sales Onboarding & Enablement Manager
About Carrier Carrier Global Corporation, global leader in intelligent climate and energy solutions, is committed to creating innovations that bring comfort, safety and sustainability to life. Thr…
Director of Strategic Sourcing
Job Description Job Description Vulcan Elements is manufacturing American rare-earth permanent magnets to enable a secure and resilient future. With a focus on national security and economic resi…
Associate Customer Service Representative Everyday Banking
Why Wells Fargo: Are you looking for more? Find it here. At Wells Fargo, we're more than a financial services leader – we’re a global trailblazer committed to driving innovation, empowering commun…
Quality Lab Technician
Job Description Job Description Quality Technician (CMM/GD&T) The Bradley Group Hours: Monday–Saturday, 7:00 AM–3:00 PM The Bradley Group is hiring a Quality Technician with experience…
Accounting Clerk - Now Hiring
Ready for a role where you can manage financial data and make an impact? Are you someone who excels at organization, has a sharp eye for details, and enjoys problem-solving? Accounting clerk positions…
Engineer II
POSITION SUMMARY Respond and attend to guest repair requests. Communicate with guests/customers to resolve maintenance issues with little to no supervision. Perform preventive maintenance on tools…
Sewers - 1st & 2nd shift
Job Description Job Description 1st & 2nd shfit pay rate $16-$18 Depending on Experience Key Responsibilities: Operate 1-needle and/or 2-needle industrial sewing machines to sew materials…
Crime Lab and Forensic Manager
Duties and Requirements Click to read more Duties Essential Tasks & Responsibilities: Directs, coordinates, assigns, observes, reviews, and evaluates the work of subordinate personne…