What are the responsibilities and job description for the Automation / CSV Lead position at TekOne IT Services Pvt. Ltd.?
Title: Automation / CSV Lead
Location: Brunswick, NJ
Duration: Long Term
Job Description
Key Responsibilities:
Location: Brunswick, NJ
Duration: Long Term
Job Description
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.
- 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.
