Senior Validation Lead

22 hours ago

Chennai, Tamil Nadu, India beBeeValidation Full time ₹ 15,00,000 - ₹ 28,00,000

Job Title: Senior Validation Engineer – CSV, CQV & Cleaning

Location: Remote

Position Type: Part-time

  • We are seeking an experienced Senior Validation Engineer with a decade of proven expertise in Cleaning Validation, Computer System Validation (CSV), and CQV (Commissioning, Qualification, and Validation) within the pharmaceutical and medical device industries.
  • The ideal candidate will drive compliance, ensure product and process integrity, and support regulatory submissions in line with global standards.

Key Responsibilities:

  • Cleaning Validation:
    • Develop and execute cleaning validation master plans, protocols (IQ/OQ/PQ), and reports.
    • Perform risk assessments (e.g., MACO calculations, swab and rinse methods).
    • Evaluate equipment and process designs for cleanability.
    • Define and execute cleaning hold time studies.
    • Support cross-functional teams in investigations and CAPAs related to cleaning failures.
  • CSV (Computer System Validation):
    • Lead the validation lifecycle of GxP systems (ERP, LIMS, MES, SCADA, PLCs, etc.).
    • Prepare validation deliverables: URS, FS, RTM, IQ/OQ/PQ, and validation summary reports.
    • Ensure 21 CFR Part 11 and Annex 11 compliance for electronic records and signatures.
    • Collaborate with IT, QA, and system owners for periodic reviews, revalidation, and audits.
    • Provide guidance during data integrity assessments.
  • CQV (Commissioning, Qualification, and Validation):
    • Lead end-to-end CQV activities for equipment, utilities (HVAC, PW/WFI), and facilities.
    • Author and execute protocols for FAT, SAT, IQ, OQ, and PQ in alignment with ASTM E2500 or traditional V-model.
    • Support technology transfer, scale-up, and new product introduction projects.
    • Coordinate with Engineering, Manufacturing, and QA during project execution.

Required Skills and Qualifications:

  • Bachelor's / Master's degree in Pharmacy, Biotechnology, Engineering, or Life Sciences.
  • Minimum 10 years of relevant experience in CSV, Cleaning Validation, and CQV.
  • Experience in both pharmaceutical and medical device environments.
  • Strong understanding of FDA, EU Annex 15, ICH Q7/Q8/Q9/Q10, and ISO 13485.

Benefits:

  • Competitive compensation package.
  • Opportunity to work with a dynamic team.
  • Professional growth and development opportunities.

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