Calibration & Metrology Lead
Strive Pharmacy•Alachua, FL
•$90,000 - $100,000•Onsite
About The Position
The Calibration & Metrology Lead provides technical leadership and strategic oversight for the site’s calibration program. This role is responsible for ensuring that all instrumentation used in the production, storage, and testing of compounding products remains in a state of control and compliance. The Calibration & Metrology Lead manages high-level technical investigations, oversees junior staff or contract technicians, and serves as the primary technical point of contact during regulatory inspections.
Requirements
- B.S. or M.S. in Engineering (Electrical, Mechanical, or Chemical) or Physics.
- 10+ years of experience in Metrology and Calibration within a GMP-regulated environment (Pharma/Biotech).
- At least 2 years in a "Lead" or "Senior" capacity.
- Advanced knowledge of Uncertainty Analysis, Test Uncertainty Ratios (TUR), and Guard Banding.
- Expertise in calibrating specialized equipment: bioreactors, lyophilizers, autoclaves, and utility systems.
- Experience in NIST traceability requirements and ISO 17025 standards.
- Proven ability to lead cross-functional teams and communicate technical risks to executive leadership.
- Expert-level proficiency in Blue Mountain RAM, Maximo, or SAP Plant Maintenance.
- Ability to do cleanroom gowning protocols for ISO 5/7 cleanroom environments.
- Ability to access mechanical mezzanines and rooftop utility areas.
- Able to lift and move up to 50 lbs repeatedly
Responsibilities
- Act as the Subject Matter Expert (SME) for all metrology-related matters, providing guidance on complex instrumentation issues across the facility.
- Develop and maintain the Metrology Strategy, including the selection of site-wide calibration standards and the optimization of calibration intervals using reliability-centered maintenance (RCM) principles.
- Lead the implementation and configuration of the Calibration Management Software (CCMS/CMMS), ensuring data integrity and alignment with 21 CFR Part 11.
- Oversee the Out-of-Tolerance (OOT) program, ensuring thorough investigations are conducted to determine potential impact on product quality and safety.
- Audit and manage External Calibration Vendors, ensuring their standards are traceable to NIST and their quality systems meet GMP requirements.
- Authors and approves high-level documents, including the Calibration Master Plan, complex SOPs, and Technical Assessments.
- Defend the calibration program during FDA, and internal quality audits.
- Lead the commissioning and qualification (C&Q) of new instrumentation for large-scale capital projects.
- Review and approve User Requirement Specifications (URS) and Functional Specifications for new process equipment to ensure measurement accuracy requirements are met.
- Collaborate with Process Engineering to solve recurring instrumentation failures or drift issues through root cause analysis (RCA).
- Supervise, mentor, and train junior Metrology and Calibration Technicians.
- Establish Key Performance Indicators (KPIs) for the metrology department, such as calibration completion rates, OOT frequency, and technician productivity.
- Drive continuous improvement initiatives to reduce system downtime and improve measurement reliability.
Benefits
- Employer-paid healthcare coverage, effective the 1st day of the following month of your hire date
- Free Strive compounded medications for employees based on a valid patient-specific prescription from a licensed healthcare provider
- Paid time off
- Sick time
- FSA and HSA options
- Parental leave
- 401(k) with employer matching
- Life insurance
- Vision and dental insurance
- Veterinary insurance
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What This Job Offers
Job Type
Full-time
Career Level
Senior
