Lead Calibration Technician

Salary Range: $60,000.00 To $80,000.00 Annually

The Lead Calibration Technician will oversee and execute calibration activities for critical (and non-critical) instruments and equipment within a GMP manufacturing facility. This role ensures accurate and reliable performance of measurement systems supporting production and quality processes. Responsibilities include maintaining compliance with ISO 17025, ISO 13485, FDA regulations, and cGMP standards. The position requires advanced technical expertise in calibration, strong troubleshooting skills, and leadership capabilities to guide junior technicians and contractors.

This position is primarily on-site at the Bedford, MA facility, with some flexibility for hybrid work depending on project needs and team coordination.

• Lead and perform calibration, verification, and adjustment of instruments and equipment in compliance with ISO 17025, ISO 13485, and GMP requirements.
• Develop and maintain calibration schedules, ensuring timely completion of all required activities per regulatory standards.
• Administer and maintain CMMS (preferably Blue Mountain RAM), ensuring accurate asset data, calibration intervals, work order tracking, and documentation.
• Create and maintain SOPs and work instructions for the lifecycle of calibrated assets in alignment with industry standards and best practices.
• Ensure calibration records are complete, traceable, and compliant with FDA, ISO, and internal standards.
• Troubleshoot and resolve calibration-related issues promptly while adhering to safety and compliance standards.
• Establish service agreements and maintain relationships with calibration vendors and equipment suppliers ensuring reliable, timely and appropriate calibration.
• Train and mentor junior technicians; act as a subject matter expert for calibration systems and compliance requirements.
• Support installation, qualification, and validation of new instruments and equipment, ensuring adherence to ISO and GMP protocols.
• Participate in investigations, root cause analysis, and continuous improvement initiatives related to measurement systems.
• Generate and analyze metrics (e.g., calibration completion rates, equipment downtime, backlog) to drive continuous improvement.
• Maintain accurate documentation of all calibration activities in CMMS or other approved systems, ensuring compliance with GDP.
• Participate in on-call rotation for off-hour emergencies and weekend walkthroughs as needed.

• Bachelor’s degree in Engineering, Life Sciences, or related field (or equivalent experience).
• 5+ years of calibration experience in a regulated pharma or medical device environment.
• Hands-on experience with CMMS platforms;
  Blue Mountain RAM (BMRAM) strongly preferred.
• Strong knowledge of ISO 17025, ISO 13485, FDA 21 CFR Part 11, and GMP compliance.
• Strong analytical, organizational, and communication skills.
• Ability to work independently and lead a team effectively.
• Proficiency in Microsoft Office Suite and data visualization tools.

• Experience in Biotech/Pharmaceutical or Medical Device manufacturing facilities.
• Familiarity with equipment qualification, calibration protocols, and validation lifecycle.
• Lean or Six Sigma certification is a plus.
• Excellent communication and time management skills.
• Ability to read and interpret engineering drawings, calibration certificates, and technical manuals.

The salary range provided is based on the Company’s reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more.

At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life.

The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.

We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.