Validation Engineer II
Validation Engineer II
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Salary Not Disclosed
1 Vacancy
Job Description
Work Schedule
Standard Office Hours (40/wk)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards OfficeJob Description
As an Engineer II in Validation at Thermo Fisher Scientific youll contribute to impactful global health projects.
Key Responsibilities:
- Manage lead schedule and complete multiple high-complexity projects with multidisciplinary departments to ensure flawless results.
- Serve as the principal validation liaison negotiating with clients on agreements and resolving significant validation product and regulatory issues.
- Prepare review and approve production validation and audit reports as well as master batch record documents procedures and rationales.
- Evaluate new regulations and changes to existing ones performing gap analysis to determine and address deficiencies.
- Establish and implement systems to achieve process improvements and efficiencies.
- Coordinate regulatory inspections performed by the FDA MCA and other agencies.
- Defend policies procedures rationales and methods during regulatory and client audits.
- Establish and supervise quality programs and plans such as validation QAT and supplier certification.
Qualifications:
- High School Diploma or equivalent experience required.
- Bachelors degree in Engineering or a Biological science-related field preferred. Four years of relevant experience may substitute for a degree.
- Proven work experience in the pharmaceutical or regulated industry preferred.
- Capability to thrive in a fast-paced environment while managing multiple tasks effectively.
- Outstanding time management and prioritization skills.
- Outstanding interpersonal skills for maintaining effective working relationships with highly effective verbal and written communication skills.
Join us and be part of an ambitious team that drives technological innovation solves complex scientific challenges and supports patients in need. Help us make the world healthier cleaner and safer!
Employment Type
Full-Time
