Validation Engineer III
About The Position
As a Validation Engineer III, you will lead validation and qualification work for TruBio software and bioprocessing equipment. You will own key validation deliverables, guide junior engineers, and work with Engineering, Software, Quality, and Field Service to deliver reliable, audit-ready systems. What will you do? Lead validation projects from planning to closeout. Write and execute FAT, SAT, IQ, and OQ protocols. Resolve issues found during testing and document results. Lead customer-facing FAT activities and support audits. Partner with Field Service during Commissioning & Qualification. Support risk assessments, traceability, and deviation investigations. Improve validation templates and processes. Mentor junior engineers and support digital validation tools.
Requirements
- Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field; equivalent experience considered.
- 5 years of validation experience in biotech, pharma, or regulated manufacturing (3 years with advanced degree or equivalent work experience).
- Experience leading FAT/SAT/IQ/OQ activities.
- Customer-facing experience during qualification or FAT.
- Familiarity with CSV principles and tools like ValGenesis or Kneat.
- Hands-on experience with DeltaV, PLC/SCADA, or similar systems.
- Experience mentoring or supporting junior engineers.
- Strong knowledge of GAMP, cGMP, GDP, and 21CFR Part 11 compliance.
- Strong technical writing and communication skills.
- Good problem-solving and documentation accuracy.
- Proficient in Microsoft Office; VBA or scripting is a plus.
- Organized, adaptable, and effective in a fast-paced environment.
Nice To Haves
- Advanced degrees or validation/quality certifications are a plus.
Responsibilities
- Lead validation projects from planning to closeout.
- Write and execute FAT, SAT, IQ, and OQ protocols.
- Resolve issues found during testing and document results.
- Lead customer-facing FAT activities and support audits.
- Partner with Field Service during Commissioning & Qualification.
- Support risk assessments, traceability, and deviation investigations.
- Improve validation templates and processes.
- Mentor junior engineers and support digital validation tools.
Benefits
- 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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
