CSV Lead
About The Position
The CSV Lead will be responsible for providing visibility of the overall CSV performance, execution planning, timeline management, and in alignment with the client DeltaV Upgrade Team or other CSV Teams. This role requires the capability to serve as a Document Controller for all CSV documentation, ensuring all documentation is loaded, reviewed, and approved in Quality Docs (Veeva). The position involves engaging with Quality Docs (Veeva) to access and manage all validation documentation. Validation execution will be performed electronically, requiring familiarity with or training in Application Lifecycle Management (ALM) tools or Kneat. Test scripts will be generated, approved, executed, and verified post-execution on an electronic platform or any other electronic system in accordance with client procedures. Experience in the DeltaV DCS platform and associated validation activities is essential.
Requirements
- Bachelor’s Degree in Science (Computer System or Engineering preferred).
- Six (6) years of exposure in Computer System Validation within the Pharmaceutical Industry.
- Excellent communication skills (oral, written and reading) in Spanish and English.
- Strong hands-on experience leading CSV activities for DeltaV DCS systems within regulated pharmaceutical or biotech environments.
- Experience in validation lifecycle management and system upgrades.
- cGMP / 21 CFR Part 11 / GAMP 5 Compliance Expertise.
- Experience with Electronic Validation Execution Tools.
- Ability to analyze data and identify inconsistencies.
- Skilled multitasker with an incredible ability to set priorities.
- Commitment to serving customers with high-quality research and products.
- Embracing a diverse work culture.
- Commitment to the environment.
- Experience in DeltaV DCS platform and associated validation activities.
Nice To Haves
- Familiarity with Application Lifecycle Management (ALM) tools or Kneat.
Responsibilities
- Provide visibility of the overall CSV performance, execution planning, and timeline management.
- Align with the client DeltaV Upgrade Team or other CSV Teams.
- Serve as Document Controller for all CSV documentation.
- Load, review, and approve all documentation in Quality Docs (Veeva).
- Engage with Quality Docs (Veeva) to access and manage all validation documentation.
- Execute validation electronically using ALM tools or Kneat.
- Generate, approve, execute, and verify test scripts on an electronic platform.
- Utilize the DeltaV DCS platform and associated validation activities.
Benefits
- Excellent, unmatched, never-before-seen customer service of our team.
- Flexible, family-oriented company culture.
- Focus on resources' well-being.
- Top-notch quality talent provision to clients.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
