Validation Engineer

ATS Global; Mumbai; On-site; INR 700,000 - 1,200,000; Full time

Job summary

ATS Global is seeking a Validation professional to drive CSV deliverables, GAMP 5 validation, URS/FRS, IQ/OQ/PQ protocols and ensure data integrity aligned with QCMS, ISMS, GMP/GDP/QMS practices. The role is on-site in India, within the Validation department.

Ideal candidates have 2–5 years of experience, a Graduate/Master's in Pharmacy or B.E./B.Tech, and familiarity with enterprise-level validation standards and documentation.

Qualifications

• 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.

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.
• Prepare Impact Assessments, QRM/QRA documents.
• Comply with QCMS, ISMS, and client GMP/GDP/QMS practices.

Skills

GAMP 5

21 CFR Part 11

EU Annex 11

Data Integrity

Quality Systems

Education

Graduate/Master's in Pharmacy or B.E./B.Tech

Tools

DCS

LIMS

QMS

DMS

LMS

CDAS

MES

BMS

EMS

Job description

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.

Disclaimer: This job posting and Location 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.