Clean Equipment Specialist

2 weeks ago

Chennai, Tamil Nadu, India beBeeValidation Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

We are seeking a seasoned Senior Validation Specialist to drive quality assurance, ensure product and process integrity, and support regulatory submissions in line with global standards.


Key Responsibilities:
  • Develop and execute comprehensive validation 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.
  • 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.
  • 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.

Requirements:
  • 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.

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