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Company

Original Job Post

Thermo Fisher Scientific · 1 week ago

Engineer III, Validation

Cambridge, MA

Full-time

Onsite

Mid Level

3+ years exp

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BioinformaticsBiotechnology

H1B Sponsorship

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Responsibilities

Plan and execute validation projects including working with the Thermo Fisher core teams to understand the scope of validation activities and develop schedule, budget, resource plans to meet overall project objectives;

Act as a subject matter expert supporting sites during audits and inspections as needed;

Generate, review and approve departmental documentation (e.g., SOPs, protocols, final reports, data trends);

Author and participate in document revisions, providing input, as necessary;

Coordinate with stakeholders for validation project initiatives, including protocol generation, execution and closeout;

Provide leadership and expertise for validation activities during the tech transfer of new products in the manufacturing facility;

Provide leadership and expertise for the CQV revalidation program for the site;

Establish and maintain cross-site relationship with other relevant sites to promote and maintain best practices.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

CGMP ManufacturingValidation ActivitiesChange ControlFacility QualificationsEnvironmental MonitoringEquipment QualificationBioreactorsMix TanksChambersTangential Flow FiltrationUtility QualificationWFIPurified WaterClean SteamProcess GassesHVACVaporized Hydrogen Peroxide

Required

Master’s degree in Mechanical Engineering, Biochemical Engineering, Chemical Engineering, Electrical Engineering, Biology, or related field of study

Three years of experience in a cGMP manufacturing environment or related experience

Knowledge or experience with validation activities including plan and protocol generation, execution, and final report approval/closeout

Change control and performing validation impact assessments

Conducting facility qualifications, including environmental monitoring (EM) testing for process cleanrooms (ISO and EU classification)

Performing equipment qualification activities for bioreactors, mix tanks, chambers, tangential flow filtration (TFF), drug product filler

Performing utility qualification activities for WFI, purified water, clean steam, process gasses, HVAC, vaporized hydrogen peroxide (VHP)

Company

Thermo Fisher Scientific

Glassdoor

3.6

Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.

Founded in 1956

Waltham, Massachusetts, USA

10,001+ employees

http://www.thermofisher.com

H1B Sponsorship

Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (173)

2022 (314)

2021 (349)

2020 (251)