Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

As an Engineer II in Validation at Thermo Fisher Scientific, you'll 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.
• Bachelor’s 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!