Department
Health & Biotech
Category
Health & Biotech
Job type
Full-Time
Experience
Not Mentioned
Description
- Lead or support Validation activities related to validation of facility, equipment, utility, computer system and sterilization for the qualification life cycle from URS, through DQ, IQ, OQ and PQ.
- Develop & execute Validation Protocols and Reports related to:
- Temperature Chambers (e.g. Freezers, cold room etc.)
- Clean utilities (e.g. WFI, clean steam, process gas etc.)
- EMPQ Clean room qualification, Autoclave, Manufacturing process equipment (e.g. bioreactors, BSC, Isolator)
- Laboratory equipment (e.g. HPLC)
- Investigate and resolve discrepancies/incidents arising from qualification activities and support validation related deviations.
- Review and approve of Validation Protocols / Reports including site discrepancies and deviations investigation / closure
- Perform Periodic review Site Validation Maintenance Program, ensuring systems remain in a validated state throughout their lifecycle.
- Develop Validation Plans for a small to medium scale change implementation project and ensure the validation execution activity meets scheduled timelines
- Coordinate with other Engineering functions, End-User and Quality team to ensure the Validation activities.
- Review Engineering documents associated with commissioning and validation activities
- Evaluate and propose improvement to equipment/system, processes and operations to improve safety and process efficiency.
- Review & assess Site Change Controls and Validation CAPAs.
- Participate in Customer / Agency Audits and Inspections.
- Participate in on-job training program and provide training to Validation staff.
Qualifications
Highest qualification: University
- Degree in engineering related fields
- Proficiency in electronic systems such as Kneat GX and Trackwise will be a plus.
- GMP experience
- Strong understanding of regulatory requirements, validation methodologies, and risk-based approaches for cleaning and sterilization processes.