Senior Validation Engineer – Male and Female

4 days ago

Chennai, Tamil Nadu, India Tek Support Full time ₹ 1,04,000 - ₹ 1,30,878 per year

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

Location:
Remote

Position Type:
Part-time

Job Summary:

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 (FDA, EMA, MHRA, etc.).

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.

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