Validation Engineer II
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Job Location:
Santa Clara County, CA - USA
Monthly Salary:
$ 72000 - 108000
Posted on:
21 hours 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 Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job Description
As a Validation Engineer II you will support validation and qualification activities for TruBio software and bioprocessing equipment. You will write and execute validation protocols partner with engineers across teams and help deliver accurate audit-ready documentation for customers.
What will you do
Support validation projects from planning through execution.
Write and complete FAT SAT IQ and OQ protocols.
Identify and resolve issues during testing with guidance from senior engineers.
Participate in customer-facing FAT activities and support documentation reviews.
Partner with Field Service during qualification and commissioning.
Help with risk assessments traceability and deviation investigations.
Improve validation templates and contribute to process updates.
Education
Bachelors degree in Engineering Computer Science Life Sciences or related field; equivalent experience considered.
Experience
2 years of validation experience in biotech pharma or regulated manufacturing (limited experience acceptable with advanced degree)
Experience with FAT/SAT/IQ/OQ execution.
Exposure to customer interactions during testing or FAT is a plus.
Familiarity with Computer System Validation (CSV) concepts.
Experience with automation systems such as DeltaV PLC/SCADA or similar is preferred.
Skills
Understanding of GAMP cGMP GDP and 21 CFR Part 11 compliance.
Strong attention to detail and documentation accuracy.
Good technical writing and communication skills.
Proficient in Microsoft Office; VBA or scripting experience is helpful.
Organized willing to learn and adaptable in a fast-paced environment.
Physical Requirements and Work Environment:
- Onsite role
- Office setting
What We Offer:
- Annual performance-based bonus
- Annual merit performance-based increase
Excellent Benefits:
- Benefits & Total Rewards Thermo Fisher Scientific
- Medical Dental & Vision benefits - Effective Day 1!
- Paid Time Off & Designated Paid Holidays
- Retirement Savings Plan
- Tuition Reimbursement
- Employee Referral Bonus
- Career Advancement Opportunities
Apply today!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status.
Compensation and Benefits
The salary range estimated for this position based in California is $72000.00$108000.00.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
