CSV & C&Q Technical Lead – Automation Validation
Techengpr
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Job summary
Technical & Engineering Consulting LLC is seeking an Automation / CSV C&Q Technical Lead to support a major pharmaceutical capital project in Puerto Rico. The role focuses on leading CSV strategy, validating computerized systems from design through handover, and ensuring compliance with GAMP 5, ALCOA+, and cGMP throughout the lifecycle.
The ideal candidate has senior CSV experience in FDA-regulated environments, strong leadership, and a proven track record in IQ/OQ/PQ, RTMs, and
Qualifications
- Bachelor's degree required in a technical field related to automation or engineering.
- Significant CSV experience within pharmaceutical, biotechnology, or FDA-regulated environments.
- Experience leading CSV activities on capital projects.
- Strong understanding of GAMP 5, 21 CFR Part 11, ALCOA+ and cGMP.
Responsibilities
- Lead the CSV strategy for the project and set validation direction.
- Define validation requirements and ensure alignment with project goals.
- Collaborate with Process Engineering to meet business needs in automation.
- Provide technical leadership during software development and testing.
- Develop and review Validation Plans, URS, FDS, DS, RTMs, Test Scripts, and VRs.
- Lead IQ/OQ/PQ execution and support FAT/SAT activities.
- Manage deviations, investigations, change controls, and validation docs.
- Create CSV training plans and monitor milestones and progress.
Skills
Education
Job description
Technical & Engineering Consulting LLC is seeking an Automation / CSV C&Q Technical Lead to support a major pharmaceutical capital project in Puerto Rico. The role focuses on leading CSV strategy, validating computerized systems from design through handover, and ensuring compliance with GAMP 5, ALCOA+, and cGMP throughout the lifecycle.
The ideal candidate has senior CSV experience in FDA-regulated environments, strong leadership, and a proven track record in IQ/OQ/PQ, RTMs, and
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