Senior Validation Engineer – Male and Female

5 days ago

Chennai, Tamil Nadu, India Tek Support Full time
Job Title: Senior Validation Engineer Trainer – CSV, CQV & Cleaning

Location: Remote

Position Type: Part-time

Job Summary:

We are seeking an experienced Senior Validation Engineer Trainer 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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