Job Title: CSV Engineer (Must be Local)
Location: South San Francisco, CA (Onsite Position)
Duration: 3+ Months/Contract
Interview Mode: 2 MS Team
Visa: Any
Client : Cellares – Biotech company.
Please don’t share the Resume if they don’t have:
Biotech/ Pharmaceuticals, Medical devices) Industry experience is a must.
One of the systems: Biosero GBG, Ignition, Tulip, or TWD Supplier Quality Management.
They need to have some experience with one of the systems: Biosero GBG, Ignition, Tulip, or TWD Supplier Quality Management.
Level: Mid-Senior
The CSV Engineer will work closely with system owners and cross-functional teams to develop and execute validation protocols, particularly for systems such as Biosero GBG, Ignition, Tulip, or TWD Supplier Quality Management. The ideal candidate will have experience with Azure DevOps and be capable of creating validation documents with minimal oversight.
Key Responsibilities:
- Collaborate with system owners to understand system requirements and develop appropriate validation strategies.
- Create and execute validation documents including but not limited to validation plans, protocols, and reports (IQ/OQ/PQ).
- Ensure all validation activities comply with regulatory requirements and industry best practices.
- Validate software systems such as Biosero GBG, Ignition, Tulip, and TWD Supplier Quality Management.
- Assist with the validation of Azure DevOps components as required.
- Provide support for the installation, configuration, and troubleshooting of validated systems.
- Conduct risk assessments and develop risk mitigation strategies.
- Review and approve technical documentation for accuracy and completeness.
- Communicate effectively with stakeholders, providing regular updates on project progress.
- Ensure timely completion of validation deliverables with minimal oversight.
Qualifications:
- Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field.
- 5+ years of experience in Computer System Validation within regulated industries (e.g., pharmaceuticals, medical devices).
- Hands-on experience with Biosero GBG, Ignition, Tulip, or TWD Supplier Quality Management,
- Experience with Azure DevOps is a plus.
- Strong understanding of GxP regulations, including FDA 21 CFR Part 11 and EU Annex 11.
- Excellent technical writing skills, with the ability to create clear, concise, and compliant validation documentation.
- Strong analytical and problem-solving skills, with the ability to work independently.
- Excellent communication skills, both written and verbal.
Thanks & Regards
Mangal Thakur
Direct: 302-306-1300
SKILLBIRD LLC.
4 Peddlers Row, Unit#5, Newark, DE 19702