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Thermo Fisher Scientific · 2 days ago
Engineer III, Validation
Plainville, MA
Full-time
Onsite
Senior Level
5+ years exp
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BioinformaticsBiotechnology
Insider Connection @Thermo Fisher Scientific
Responsibilities
Leads, schedules, and completes multiple projects of high complexity with multi-disciplinary departments to ensure accurate completion of results.
Serves as principle/validation liaison for collaborating with clients on agreements/projects and resolution of significant validation, product and regulatory issues!
Coordinates, reviews and prepares customer audit responses and reports.
Authors, performs reviews and approves production, validation, protocols and reports and/or procedures, and rationales!
Author validation plans; assist with the development of specifications for user requirements, functional requirements, and design requirements, trace matrices, validation summary reports and test protocols for installation, operation, performance of equipment, functional requirements, risk assessments, and IQ/OQ/PQ.
Review commissioning, qualification and validation related system lifecycle documentation and design specifications, commissioning and qualification protocols).
Assist with direction on equipment/process change control development (equipment, utilities, facilities, and processes) used to develop and manufacture products in a cGMP environment.
Identify protocol discrepancies from established product or process standards and provide recommendations for resolving protocol discrepancies.
Analyze validation test data to resolve whether systems or processes have met validation acceptance criteria or to identify root causes of production problems.
Evaluates new regulations, changes to existing regulations and regulatory trends; performs gap analysis to resolves deficiencies and take appropriate actions.
Defends policies, procedures, rationales and methods in the area(s) of expertise during regulatory and client audits.
Additional responsibilities assigned as needed by manager.
Qualification
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Required
Bachelor’s degree in engineering or Biological science related field preferred
5 years experience in CQV (Commissioning, qualification and validation)
Meaningful work experience in the pharmaceutical or a regulated industry, is preferred
Ability to work in a fast-paced environment with multi-tasks
Effective time management and prioritization skills
High degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle critical matters
Highly effective verbal and written communication skills
Preferred
Meaningful work experience in the pharmaceutical or a regulated industry
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
10,001+ employees
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)
Funding
Current Stage
Public CompanyTotal Funding
$11.05BKey Investors
National Grid
2023-08-07Post Ipo Debt· $2.95B
2023-03-27Grant· $0.5M
2022-11-15Post Ipo Debt· $1.29B
Leadership Team
Daniella Cramp
Senior Vice President and President
Frederick Lowery
Senior Vice President Thermo Fisher and President Customer Channels
Recent News
2024-05-26
Company data provided by crunchbase
