Validation Engineer III
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Job Location:
Santa Clara County, CA - USA
Monthly Salary:
$ 90900 - 136350
Posted on:
6 days ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard Office Hours (40/wk)Environmental Conditions
Able to lift 40 lbs. without assistance Adherence to all Good Manufacturing Practices (GMP) Safety Standards Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job Description
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.
Education
Bachelors degree in Engineering Computer Science Life Sciences or related field; equivalent experience considered.
Advanced degrees or validation/quality certifications are a plus.
Experience
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.
Skills
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.
Compensation and Benefits
The salary range estimated for this position based in California is $90900.00$136350.00.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
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
