Validation Engineer II - Thermo Fisher Scientific : Job Details

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...Validation Engineer, Validation, Engineer, Manufacturing, Technology