CSV Validation Engineer

1 day ago

Pune, Maharashtra, India E Tech Group Full time ₹ 15,00,000 - ₹ 25,00,000 per year

At E Tech Group, joining our team means joining a group of passionate and forward-thinking experts. We're one of the largest engineering and system integration firms in the United States providing value for our clients through IT automation and control solutions for more than 30 years to the Life Sciences, Mission Critical, Metals & Mining, Warehousing & Distribution, and CPG/Food & Beverage industries. Our national and global scale allows us to help our clients develop and implement standardized solutions at any of their facilities regardless of physical location or the local resources available at that site.

We are seeking a highly skilled Computer System Validation (CSV) professional with a strong pharmaceutical background to lead validation activities across GxP systems. The role involves end-to-end responsibility for ensuring computerized systems comply with regulatory requirements (21 CFR Part 11, EU Annex 11, GAMP5, FDA, MHRA, etc.) and align with industry best practices.

You will:

  • Develop, review, and execute Validation Master Plans (VMPs), Risk Assessments, IQ/OQ/PQ protocols, and traceability matrices.
  • Lead and support validation of systems such as MES, LIMS, SCADA, DCS, ERP, Laboratory instruments, and IT infrastructure.
  • Ensure compliance with cGMP, GxP, Data Integrity (ALCOA+), and global pharma regulatory standards.
  • Collaborate with QA, IT, Manufacturing, Automation, and Business teams to ensure smooth validation lifecycle management.
  • Participate in regulatory inspections and internal/external audits by providing SME-level support.
  • Maintain and update validation documentation repositories in line with SOPs and QMS requirements.
  • Provide training and mentoring to junior team members on CSV methodologies and regulatory compliance.

You have:

  • Bachelor's/Master's degree in Engineering, Computer Science, Life Sciences, or related field.
  • 3+ years of proven experience in Computer System Validation within the pharmaceutical/biotech industry.
  • Strong understanding of 21 CFR Part 11, EU Annex 11, GAMP5, Data Integrity guidelines, and cGMP regulations.
  • Hands-on experience with pharma systems: MES (e.g., Syncade, Werum PAS-X), LIMS, SCADA, DCS, Lab equipment integration.
  • Excellent documentation, SOP writing, and communication skills.
  • Experience in handling regulatory audits and inspections.
  • Ability to work independently as well as part of cross-functional global teams.

Good to Have

  • Experience with Cloud-based pharma IT solutions.
  • Knowledge of 21 CFR Part 210/211, ICH Q10, and ISPE guidelines.
  • Exposure to project management and vendor coordination

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