Validation Engineer

Travel

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.