Staff Validation Engineer
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Job Location:
Santa Clara County, CA - USA
Monthly Salary:
$ 112500 - 187500
Posted on:
10 days ago
Vacancies:
1 Vacancy
Job Summary
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 heightsJob Description
As a Staff Validation Engineer you will play a key role in ensuring our bioprocessing equipment and TruBio software systems meet the highest standards of quality and compliance. Youll 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 TruBio 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 deliverablesincluding risk assessments master plans FAT/SAT/IQ/OQ protocols and final summary reportsfor 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 ValGenesis or Kneat.
Contribute to organizational strategy by aligning validation processes with business goals and customer needs.
Education
Bachelors degree (or equivalent experience) in Engineering Computer Science or related technical field.
A Masters 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 (ValGenesis 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 $112500.00$187500.00.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: Experience:
Staff IC
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
