Automation / CSV Lead (Pharma) Job at Intellectt INC, New Brunswick, NJ

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  • Intellectt INC
  • New Brunswick, NJ

Job Description

Role: Automation / CSV Lead (Pharma)

Location: New Brunswick, NJ

Duration: 24 Months on W2

Key Responsibilities:

  • Develop and execute protocols for automation systems, including DeltaV, Building Management Systems (BMS), Building Automation Systems (BAS), and Environmental Monitoring Systems (EMS).
  • Perform Computerized Systems Validation (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 the 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 DeltaV, BMS, BAS, and EMS.
  • Strong knowledge of GAMP5, FDA regulations, and 21 CFR Part 11.
Excellent technical documentation and project management skills.

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