Role & responsibilities
- Prepare and execute Validation Master Plans (VMP) and equipment validation protocols.
- Perform DQ, IQ, OQ and PQ activities for equipment, utilities, and engineering systems as applicable.
- Validate production and maintenance equipment such as:
- HVAC systems
- Compressors
- Boilers
- Chillers
- AHUs
- Purified Water / WFI systems
- Electrical systems
- Manufacturing and packaging equipment
- Prepare and review URS, DQ, FAT, SAT, IQ, OQ and PQ documents.
- Coordinate with QA, Production, Engineering, QC and external vendors during validation activities.
- Ensure calibration and qualification of critical instruments and equipment.
- Develop and maintain SOPs, validation protocols, reports and checklists.
- Perform requalification of equipment and utilities as per approved schedules.
- Investigate validation failures, deviations, and out-of-specification results related to engineering systems.
- Support CAPA, change control and deviation management activities.
- Ensure all validation documents are complete, accurate,



traceable and compliant with GMP requirements.
- Review equipment modifications and assess their impact on the validated state.
- Maintain validation records, equipment history files and qualification documentation.
- Support internal, customer and regulatory audits by providing validation and engineering documentation.
- Monitor preventive maintenance activities for critical GMP equipment and utilities.
- Ensure engineering activities comply with safety, GMP and regulatory requirements.
- Coordinate with vendors and contractors for commissioning, qualification and validation activities.
- Prepare periodic validation status reports and compliance dashboards.

Preferred candidate profile
- Equipment and utility qualification
- IQ/OQ/PQ execution
- Validation documentation
- GMP compliance
- HVAC and utility systems knowledge
- Calibration and preventive maintenance
- Root Cause Analysis
- Change Control and CAPA
- Audit readines

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