Engineer III, Manufacturing Engineering, Validation

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

This is an outstanding opportunity to join Thermo Fisher Scientific Inc. as an Engineer III, Manufacturing Engineering in Santa Clara. Our team is ambitious, dedicated, and determined to make a significant impact in the engineering sector. We strictly adhere to the highest standards and are looking for individuals who strive for flawless execution and world-class results.

What will you do?

• Assess and define assigned validation project deliverables with outstanding attention to detail.
• Write, review, and complete project validation protocols for both standard and customized systems.
• Lead qualification executions, working closely with customers during FAT and site qualifications to ensure flawless implementation.
• Identify, raise, and resolve discrepancies, ensuring successful closeout of test documentation.
• Generate comprehensive reports summarizing implemented protocols.
• Perform detailed deviation investigations, addressing validation failures, complaints, and implementing corrective actions.
• Provide on-site support for C&Q efforts both in the US and worldwide, ensuring world-class service delivery.
• Resolve technical issues and implement effective solutions with proven efficiency.
• Act as the primary point of contact for C&Q with clients during site-based activities.

Education

• BS in Chemical Engineering or equivalent experience in engineering or another scientific field.

Experience

• 3 years of hands-on validation experience with developing and completing FAT, SAT, and IQ/OQ protocols.
• Proven experience in leading qualification project executions and closeouts.
• Self-motivated, proactive, and capable of strictly adhering to deadlines.
• Experience with DeltaV or similar automation systems.
• VBA coding experience.
• Proven experience in control systems testing, preferably within the biotech or pharmaceutical sector.

Knowledge, Skills, Abilities

• Strong understanding of GAMP, cGMP, GDP, and regulatory requirements for automated systems.
• Expertise in Computer Systems Validation.
• Outstanding attention to detail and ability to identify and address issues found during testing.
• Highly effective verbal and written communication skills, including technical authorship.
• Proficient in Microsoft Office, particularly Microsoft Word and Excel.

Compensation and Benefits
The salary range estimated for this position based in California is $100,000.00-$133,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards