Metrology Technician II
Thermo Fisher Scientific
Plainville, Massachusetts, United States
How will you make an impact? The Metrology Technician II will support scheduled and unscheduled calibrations and metrology services ensuring required non-GMP and cGMP compliant equipment are maintained. The focus of the position will be supporting the integration of new customers and operational readiness activities for an innovative commercial manufacturing facility. This role will transition into primary manufacturing operations support role in the site Facilities and Engineering team where they will support manufacturing and warehouse operations. What you will do... 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.). Use 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. Build and be a great partner with other VVS sites to develop and promote metrological standard processes and ensures compliance with Thermo Fisher (PCG/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. How you will get here... Education Bachelor's degree in a technical, or related field is preferred. High School diploma or equivalent is required. Experience Knowledge of cGMP’s, local/Federal regulatory requirements, and documentation procedures pertaining to a biopharmaceutical manufacturing plant. Ability to coordinate and prioritize to meet landmarks and timelines in a highly technical and results-orientated environment. 1 + 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 3 years of experience will be accepted. A combination of education and experience may be considered 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. Knowledge, Skills, Abilities Strong understanding of applicable regulatory requirements. Strong interpersonal and communications skills; written and oral. Comfortable supporting concurrent issues and working in an exciting, ambitious, and fast-paced environment. High ethical standards to support a professional business code of conduct. Able to lift 25 Kg Must be fluent in English
