Work Schedule

Standard (Mon-Fri)

Environmental Conditions

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

Job Description

As a Staff Validation Engineer, you will play a key role in ensuring our bioprocessing equipment and Tru Bio software systems meet the highest standards of quality and compliance. You’ll lead validation strategy, mentor others, and collaborate across teams to deliver reliable, regulatory-ready systems that empower our customers to advance global health and innovation.

What will you do?

• Lead and define validation strategies for Tru Bio software and bioprocessing systems, aligning with cGMP, GAMP 5, and customer expectations.

• Serve as the technical lead for qualification and validation, providing direction to project teams across Integration, Field Service, Software, and Quality functions.

• Develop and approve key validation deliverables—including risk assessments, master plans, FAT/SAT/IQ/OQ protocols, and final summary reports—for both standard and custom systems.

• Champion collaboration with customers, leading Factory Acceptance Testing (FAT) and supporting audits with confidence and technical expertise.

• Drive innovation and continuous improvement, finding opportunities to simplify validation processes, automate documentation, and strengthen quality systems.

• Coach and mentor engineers, promoting a culture of learning, technical excellence, and proactive problem-solving.

• Lead investigations into deviations and complaints, ensuring timely and effective root cause analysis and corrective actions.

• Partner with leadership to establish guidelines and validation standards that support digital transformation initiatives like Val Genesis or Kneat.

• Contribute to organizational strategy by aligning validation processes with business goals and customer needs.

Education

• Bachelor’s degree (or equivalent experience) in Engineering, Computer Science, or related technical field.

• A Master's degree is preferred.

• Advanced degree or professional certification in validation, automation, or quality preferred.

Experience

• 7 years of validation experience within biotechnology, pharmaceuticals, or regulated manufacturing environments.

• Proven success leading sophisticated qualification projects from planning to closeout (FAT, SAT, IQ/OQ).

• Proven track record to mentor, coach, and influence others across multiple teams.

• Hands-on experience with automation systems such as DeltaV, PLC/SCADA, or similar platforms.

• Experience implementing Computer System Validation (CSV) programs and using digital validation tools (Val Genesis, Kneat).

• Track record of improving processes and standardizing validation documentation.

Knowledge, Skills, and Abilities

• Strong understanding of GAMP 5, cGMP, GDP, and 21 CFR Part 11 compliance frameworks.

• Strong understanding of New Product Introduction (NPI) process and product Life cycles

• Excellent communication and technical writing skills, with a focus on clarity and collaboration.

• Ability to navigate complex problems and propose practical solutions.

• Skilled in Microsoft Office and familiar with scripting tools or VBA for data analysis and automation.

• Adaptable, collaborative, and energized by working in a dynamic and multi-functional environment.

Compensation and Benefits

The salary range estimated for this position based in California is $112,500.00–$187,500.00.

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