The Metrology Technician Il 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 execution of operational readiness activities for a state-of-the-art new commercial manufacturing facility. In addition, this role will be a primary manufacturing operations support role in the site Facilities and Engineering team where they will support manufacturing and warehouse operations.
" 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
" 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
" Bachelor's degree in a technical, or related field is preferred.
" High School diploma or equivalent is required.
" 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 resultsorientated environment.
" Minimum two (2) 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.
" 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.
" 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
" Ability to aseptically gown and/or sterile gown as needed.
" Required to write, read, and review documentation for extended periods.
" Specific vision requirements: close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
" Required to ascend/descend stairs (approximately 20% of the time), lift a maximum of 50 lbs., and sit for a maximum of 4 hours.
" Occasionally required to lift, walk, use hands to finger, handle, or feel; reach with hands and arms; stoop, kneel, or crouch.
" Required to wear Personal Protective Equipment (PPE).
" Daily computer use.
" May work with dry ice, liquid nitrogen cryogenics, hazardous and infectious agents, and experience marked changes in temperature.
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.