The Automation/CSV Lead will manage
the qualification of automation systems, including DeltaV, BMS, BAS, and EMS,
as well as CSV for production equipment and analytical instruments. This role
requires a deep understanding of automated control systems and experience in
computerized systems validation (CSV).<\/span>
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• Develop and execute protocols for automation systems including DeltaV, BMS,
BAS, and EMS.<\/span>
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• Perform CSV for production equipment and analytical instruments.<\/span>
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• Collaborate with engineering and CQV teams to align automation validation
activities with project timelines.<\/span>
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• Conduct risk assessments and implement mitigation strategies for computerized
systems.<\/span>
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• Oversee documentation lifecycle for CSV activities, ensuring compliance with
regulatory standards.<\/span>
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Qualifications:<\/span>
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• Bachelor’s degree in Computer Science, Engineering, or a related field.<\/span>
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• 10+ years of experience in automation and CSV within the pharmaceutical
industry.<\/span>
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• Expertise in DeltaV, Building Management Systems (BMS), BAS, and Environmental
Monitoring Systems (EMS).<\/span>
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• Strong knowledge of GAMP5, FDA regulations, and 21 CFR Part 11.<\/span>
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• Excellent technical documentation and project management skills.<\/span>
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