Validation Engineer

You will be responsible for driving CSV deliverables, GAMP 5 validation, URS/FRS, IQ/OQ/PQ protocols, and stakeholder-aligned solutions, while ensuring data integrity and compliance with QCMS, ISMS, and GMP/GDP/QMS practices.

Employment Type

Full-Time

Location

On-site (India)

Department

Validation

Qualification

Graduate / Master s degree in Pharmacy, or B.E/B. Tech in technical stream.

Experience Required

2-5 Years

Travel

Yes, 100% PAN India

Job Requirements (Skill Sets)

• Knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, PIC/S, WHO, MHRA, ISMS, cGMP, GDP, and Data Integrity.

• Experience in review/execution of validation documents like FS, CS, SDS, IQ, OQ and ability to draft FS/CS/DS.

• Understanding of risk, impact, criticality, and effects on patient safety, product quality, and data integrity; good knowledge of FMEA.

• Ability to read P&ID diagrams, PLC ladder logic, program configuration, and system design.

• Experience/functional expertise in at least one system: DCS, LIMS, QMS, DMS, LMS, CDAS, MES, BMS, EMS.

• Understanding of system architecture, data flow, and I/O verification.

• Good English communication and basic knowledge of IT infrastructure/network validation.

• Willing to work onsite across India.

• Preferred candidates with experience in enterprise-level software.

  Key Responsibilities

• Prepare and execute CSV deliverables as per GAMP 5.

• Work with cross-functional teams to develop URS/FRS, Validation Plan, CS, IQ/OQ/PQ protocols.

• Provide timely status updates, maintain project trackers, and ensure on-time delivery.

• Execute validation activities with strict adherence to data integrity.

• Coordinate with stakeholders to ensure alignment with project objectives.

• Develop Validation Plans, Functional Specs, and Design Docs based on system architecture understanding.

• Quickly learn new technologies and prepare related configuration/design documents.

• Prepare Impact Assessments, QRM/QRA documents.

• Comply with QCMS, ISMS, and client GMP/GDP/QMS practices.

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