Computer System Validation Lead
On-site
Contractor
#Technology
#Risk
#Change Management
#Management
#Testing
#Validation
At our organization, we are dedicated to ensuring the highest standards of quality and compliance within the life sciences sector. We build robust systems that support manufacturing and distribution processes, helping our clients navigate complex regulatory landscapes with precision. By joining our team, you will play a vital role in maintaining the integrity of our technological infrastructure and safeguarding the critical processes that bring essential products to market.
The role
We are looking for a Computer System Validation Lead to join us as a contractor. This is a senior-level position that requires you to work on-site at our client facility located in Foster City, California. You will be responsible for overseeing complex validation efforts and ensuring that our systems meet rigorous industry standards.
Core responsibilities
- Lead and manage all testing and validation activities to ensure they align perfectly with project objectives, schedules, and defined scopes.
- Oversee change management procedures, drawing on your extensive experience with handling over 20 change requests to maintain system stability.
- Direct the implementation of risk-based validation strategies while maintaining hands-on control over deviation and CAPA management processes.
Skills and experience
To succeed in this role, you should have a strong background in technology and risk management. We require the following qualifications:
- Deep knowledge of 21 CFR Part 210 and 211 regulations.
- Practical, hands-on experience with GAMP 5 risk-based validation and ICH Q9 implementation.
- Proven experience managing large-scale system upgrades or implementations.
- Formal training or professional certification in testing and validation.
- Excellent technical writing and communication skills in English.
- The ability to work independently and thrive in cross-functional environments while liaising with business stakeholders.
Compensation and benefits
This position offers the opportunity to work on high-impact projects within a professional environment. While we do not have specific salary information to share at this time, we provide a focused, collaborative workspace where you can apply your expertise to meaningful technical challenges.
How to apply
If you have the technical expertise and leadership experience we need, we would love to hear from you. Please submit your application, including your resume and a summary of your relevant validation experience, so we can review your qualifications for this on-site opportunity.
