More jobs:
Automation/CSV Lead
Job in
New Brunswick, Middlesex County, New Jersey, 08933, USA
Listed on 2025-11-27
Listing for:
Pharmatek Consulting Inc.
Full Time
position Listed on 2025-11-27
Job specializations:
-
Engineering
Systems Engineer, Software Engineer, Electrical Engineering, Engineering Design & Technologists
Job Description & How to Apply Below
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
The Automation/CSV Lead will manage the qualification of automation systems, including Delta
V, 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 Delta
V, 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.
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 Delta
V, 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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