Work ScheduleFirst Shift (Days)
Environmental ConditionsAble to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degrees, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job DescriptionAs part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Location/Division Specific InformationAt the Plainville site within the Viral Vector Services (VVS), a division of ThermoFisher Scientific, we deliver Advanced Therapeutics from process development through commercial supply, and we offer the expertise and resources vital to help clients deliver innovative gene therapies.
Discover Impactful Work: 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.
A Day in the Life:- 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 detail 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 phenomenal 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.
Keys to Success: Education- High school diploma or equivalency required.
- Bachelor's degree in a technical, or related field is helpful.
Preferred Experience:- 1 year of meaningful experience in a regulated environment with a degree, or 2 years of experience in lieu of a degree is preferred.
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.
- 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.
- 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.
BenefitsWe offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!