Biopharma Metrology Technician — GMP Calibration

ThermoFisher Scientific; Plainville (MA); On-site; USD 66,000 - 99,000; Full time

Benefits offered by this job

Total Rewards package

401(k) plan

Employee stock purchase plan

PTO and holidays

Job summary

Thermo Fisher Scientific is seeking a Metrology Technician Ill in Plainville, MA to support calibration for manufacturing labs, utilities, and facilities equipment. You will work with CMMS and help ensure cGMP compliance across processes and projects.

The role involves gown qualification for cleanrooms, collaboration with manufacturing and QA teams, and participation in deviation investigations and change control activities. Strong regulatory knowledge is essential.

Qualifications

• Minimum four (4) years' experience in instrument calibration and repair for manufacturing, laboratories, utilities, and facilities equipment in a pharmaceutical manufacturing, or high regulatory environment is accepted with degree, and in lieu of degree 6 years of experience will be accepted.
• Knowledge of cGMP's, local/Federal regulatory requirements, and documentation procedures pertaining to a biopharmaceutical manufacturing plant.
• Ability to coordinate and prioritize to meet milestones and timelines in a highly technical and results orientated environment.
• Must be able to understand and use basic computer software packages like Excel, Word, Power Point, Internet, Blue Mountain, MAXIMO, etc.
• Ability to read and interpret mechanical, pneumatic, and electrical blueprints.

Responsibilities

• Performs calibration and metrology activities and services to assure that required process, laboratories, utilities and facilities equipment calibrations are performed in compliance with NIST, cGMP regulations, company policies and procedures and meet Federal and local governmental regulation (e.g. FDA, EQB, OSHA, etc.).
• Utilizes the Computerized Maintenance Management System (CMMS) to document calibration activities
• Gown qualification for support of cleanroom activities
• Identify any areas where non-compliance or non-harmonization is occurring
• Helps drive continuous improvements
• Participate in deviation investigations and supports change control assessments and reviewing/approving change control implementation plans
• Builds and maintains relationships with other VVS sites to develop and promote metrological best practices and ensures compliance with Thermo Fisher (PSG/VVS) SOP's, safe work practices, and cGMP regulations.
• The position involves close collaboration with Manufacturing, Manufacturing Sciences, Quality Assurance, Quality Control, and other Engineering teams

Education

High School diploma or equivalent

Tools

CMMS

MAXIMO

Blue Mountain

Excel

Word

PowerPoint

Internet

Job description

Thermo Fisher Scientific is seeking a Metrology Technician Ill in Plainville, MA to support calibration for manufacturing labs, utilities, and facilities equipment. You will work with CMMS and help ensure cGMP compliance across processes and projects.

The role involves gown qualification for cleanrooms, collaboration with manufacturing and QA teams, and participation in deviation investigations and change control activities. Strong regulatory knowledge is essential.