Work Schedule
First Shift (Days)
Environmental Conditions
Able 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 -22degreesF/-6degrees C, Laboratory Setting, Loud Noises (Equipment/Machinery), No contact lens allowed; prescriptive glasses will be provided, Office, Rapid flashing lights, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse, Working at heights
Job Description
Location/DivisionSpecific 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.
How will you make an impact?The Metrology Technician Ill will support scheduled and unscheduled calibrations and metro logy services ensuring required non-GMP and cGMP compliant equipment are maintained. The initial focus of the position will be supporting the execution of a large capital facility project from construction and operational readiness activities for a state-of-the-art new 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 will you 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.).
- 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
- How will you get here?
Education
- 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 milestones and timelines in a highly technical and results orientated environment.
- 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.
- 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.
- 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.
Benefits
We 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!
Other
Relocation assistance is not provided.
Must be legally authorized to work in the United States now and in the future, without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.
Compensation and Benefits
The salary range estimated for this position based in Massachusetts is $66,000.00–$99,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
