JDE Techno Functional

xperience Required:

Over all 6-10 years of experience in pharmaceutical / biotech validation within a regulated (GxP) environment

Job Summary:

We are looking for a skilled Validation Engineer having experience in end-to-end validation (with Kneat Gx platform) in pharmaceutical manufacturing environments to ensure that computerized and automated systems comply with regulatory requirements. The candidate will be responsible for end-to-end validation activities, ensuring compliance with GxP, GAMP 5, and 21 CFR Part 11, and maintaining data integrity across systems.

Required Skills:

• Strong understanding of pharmaceutical validation lifecycle (CSV).
• Hands-on experience in protocol writing and execution (IQ/OQ/PQ).
• Experience in risk-based validation methodologies.
• Strong documentation, review, and compliance skills.

In-depth knowledge of:

• GxP / GMP requirements
• GAMP 5 guidelines
• 21 CFR Part 11 & EU Anex 11
• Data integrity (ALCOA+ principles)

Key Responsibilities:

1. Perform Computerized System Validation (CSV) for Manufacturing, Clinical, Enterprise level systems using Kneat Gx validation platform.
2. Perform risk assessments (FMEA / risk-based validation) to define validation scope and strategy
3. Prepare, review, and execute validation deliverables (VMP, URS, FS, DS, IQ, OQ, PQ etc) in Kneat Gx.
4. Execute validation protocols and document results in compliance with SOPs and GMP guidelines.
5. Record & resolve exceptions, non-conformities occurred during execution.
6. Take ownership of exception assessment and closure in coordination with local stakeholder team.
7. Collaborate with relevant stakeholder teams to perform the validation activities.
8. Experience in sterile / API / formulation plants is preferred.
9. Support internal and external audits and inspections (FDA, MHRA, WHO, etc.) is desirable.

Key Competencies:

1. High attention to detail and compliance mindset.
2. Strong analytical and problem-solving skills.
3. Effective communication with cross-functional teams.
4. Ability to work in audit-driven environments.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.