Calibration & Metrology Lead
Alachua, Florida, United States of America
Full Time
2 weeks ago
$90,000 - $100,000 USD
No H1B
Key skills
CSAPLeadershipProject Management
About this role
Company Overview:
Strive Pharmacy is a personalized compounding pharmacy built on a simple conviction: medicine should fit the patient, not the other way around. We started Strive because we believed the pharmaceutical industry was overdue for a more human approach—one that prioritizes individualized care, clinical nuance, and genuine partnership with patients and providers.
Compounding gives us the tools to do that. Every formulation we prepare is built to the specific needs of a specific person, and every interaction we have is guided by that same commitment to personalized care.
We're growing, and we're looking for people who share that conviction. If you're ready to be part of a pharmacy that takes the work seriously and the people even more seriously, we'd like to meet you.
Mission:
Strive exists to disrupt an industry long overdue for a more personal approach to care. We put the human element at the center of everything: every formulation, every patient interaction, every provider partnership. We're not just a compounding pharmacy. We're a team on a mission to change what personalized healthcare looks and feels like.
Position Type: Full-Time
Location: Alachua, FL (Onsite Monday - Friday)
Salary: $90,000 - $100,000
Reports To: Director of Facilities & Engineering
Position Summary
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.
Key Responsibilities
Technical Leadership & Strategy
- 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.
Program Oversight & Compliance
- 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.
Engineering & Project Management
- 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).
Mentorship & Operational Excellence
- 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.
Qualifications & Skills
- Education: B.S. or M.S. in Engineering (Electrical, Mechanical, or Chemical) or Physics.
- Experience: 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.
- Technical Knowledge:
- 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.
- Soft Skills: Proven ability to lead cross-functional teams and communicate technical risks to executive leadership.
- Software: Expert-level proficiency in Blue Mountain RAM, Maximo, or SAP Plant Maintenance.
Physical Requirements
- 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
Work Environment: This position is primarily based in an onsite work environment. The role requires regular periods of sitting, standing, and computer use, with occasional lifting as needed. Reasonable accommodations may be made for individuals with disabilities.
Annual Salary
$90,000—$100,000 USD
Join Us in Making an Impact:
At Strive, the work is real and the impact is direct. Every role here contributes to a patient experience that's more personal, more attentive, and more human than what most people have come to expect from a pharmacy. Apply today and help us raise the bar.
Benefits/ Perks:
Strive Pharmacy offers a comprehensive benefits package, including:
- 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
Culture:
Culture isn't an afterthought at Strive. It's something we actively build. At our Gilbert, Arizona location, that looks like Food Truck Fridays and Casual Fridays. Company-wide, we also celebrate throughout the year with holiday potlucks and seasonal gatherings. We're committed to supporting the personal and professional growth of every employee, inside and outside the workplace.
EEO:
Strive Pharmacy is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristics as outlined by federal, state or local laws.
Disclaimer*** Please do not call the pharmacy location with questions about your application or interview. A talent acquisition partner will reach out to you.