Metrology Technician Ill

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

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

As 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 Information

At 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.
• Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 90,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.