consultpharmatek
New Brunswick, United States | Posted on 10/02/2024
Industry: Pharma/Biotech/Clinical Research
Job Type: Contract
Work Experience: 5+ years
State/Province: New Jersey
Country: United States
Job Description
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). Key Responsibilities:
Develop and execute protocols for automation systems including DeltaV, BMS, BAS, and EMS. Perform CSV for production equipment and analytical instruments. Collaborate with engineering and CQV teams to align automation validation activities with project timelines. Conduct risk assessments and implement mitigation strategies for computerized systems. Oversee documentation lifecycle for CSV activities, ensuring compliance with regulatory standards. Requirements
Qualifications: Bachelor’s degree in Computer Science, Engineering, or a related field. 10+ years of experience in automation and CSV within the pharmaceutical industry. Expertise in DeltaV, Building Management Systems (BMS), BAS, and Environmental Monitoring Systems (EMS). Strong knowledge of GAMP5, FDA regulations, and 21 CFR Part 11. Excellent technical documentation and project management skills.
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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). Key Responsibilities:
Develop and execute protocols for automation systems including DeltaV, BMS, BAS, and EMS. Perform CSV for production equipment and analytical instruments. Collaborate with engineering and CQV teams to align automation validation activities with project timelines. Conduct risk assessments and implement mitigation strategies for computerized systems. Oversee documentation lifecycle for CSV activities, ensuring compliance with regulatory standards. Requirements
Qualifications: Bachelor’s degree in Computer Science, Engineering, or a related field. 10+ years of experience in automation and CSV within the pharmaceutical industry. Expertise in DeltaV, Building Management Systems (BMS), BAS, and Environmental Monitoring Systems (EMS). Strong knowledge of GAMP5, FDA regulations, and 21 CFR Part 11. Excellent technical documentation and project management skills.
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