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Thermo Fisher Scientific · 3 days ago
Validation Engineer III
Greenville, NC
Full-time
Onsite
Mid Level
4+ years exp
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Responsibilities
Manages, leads, schedules, executes, and supervises multiple projects of high complexity with multi-disciplinary departments to ensure on-time completion of deliverables.
Serves as principal/validation liaison for negotiating with clients on agreements/projects and resolution of significant validation, product, and regulatory issues.
Prepares, reviews, and approves production, validation, audit reports, and/or master batch record documents, procedures, and rationales.
Evaluates new regulations, changes to existing regulations, and regulatory trends; performs gap analysis to determine deficiencies and take appropriate actions.
Establishes actions and implements systems to achieve process improvements and efficiencies to address shortcomings in processes and systems.
Serves as principal in hosting and coordinating regulatory inspections performed by the FDA, MCA, and other regulatory agencies.
Defends policies, procedures, rationales, and methods in the area(s) of expertise during regulatory and client audits.
Establishes and supervises quality programs and plans (e.g. validation, QAT, supplier certification).
Qualification
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Required
Associate's degree
Four (4) years of relevant work experience in the pharmaceutical or a regulated industry
Two (2) years of validation experience
Ability to work in a fast-paced environment under pressure and able to multi-task
Effective time management and prioritization skills
Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters
Highly effective verbal and written communication skills
Preferred
Bachelor’s degree in Engineering or Biological science related field
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
