Senior Validation Engineer – Male and Female

Job Title:

Location:

Position Type:

Job Summary:

Senior Validation Engineer

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.

Regulatory & Compliance:

• Ensure compliance with cGMP, GAMP 5, FDA, EMA, WHO, and ISO 13485 standards.
• Support internal and external audits; provide SME support during regulatory inspections.
• Maintain comprehensive validation documentation for audit readiness.

Required 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

  .

Preferred Skills:

• Excellent documentation, technical writing, and project management skills.
• Proficient in using validation tools, spreadsheets, and regulatory databases.
• Cross-functional communication and stakeholder engagement.
• Experience in automation and data integrity tools is a plus.

Certifications (Preferred but not required):

• GAMP 5 Certification
• Lean Six Sigma (Green/Black Belt)
• PMP or similar project management certification.