Project CSV Lead EngineerIntellectt Inc • Indiana, PA, US
Project CSV Lead Engineer
Intellectt Inc • Indiana, PA, US
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job_description.job_card.job_descriptionBachelor's degree in Engineering or related field. 10+ years of CSV experience in pharma / biotech environments. Strong experience leading validation or automation projects. Hands-on experience with Kneat or similar validation tools. Knowledge of GAMP 5 21 CFR Part 11 , and Annex 11 Mid-Senior level Contract Pharmaceutical Manufacturing and Biotechnology Research
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The Project CSV Lead Engineer will lead and manage Computer System Validation (CSV) activities for multiple projects under the Foundry Program. This role ensures all systems and documentation meet quality and regulatory compliance standards.
Key Responsibilities
- Plan and manage CSV deliverables such as Validation Plans, Security Plans, and Test Plans.
- Collaborate with QA, SMEs, and project teams to ensure compliance and timely execution.
- Lead electronic test case execution and troubleshooting using Kneat
- Oversee documentation, change control, and configuration management.
- Generate progress reports and ensure accurate tracking of validation activities.
- Support onboarding and training of validation personnel.
- Provide mentorship to automation and validation engineers.
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Lead Project Engineer • Indiana, PA, US