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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