Senior Validation Engineer — GMP Biotech (On-Site)

Lonza Group Ltd.; Singapore; Presencial; SGD 67.000 - 100.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Fully paid medical insurance

Daily MRT bus to Tuas site

Descripción de la vacante

Lonza Group Ltd. in Singapore Tuas is seeking a Validation specialist to support day-to-day validation activities for facilities, equipment, utilities and systems. The role requires collaboration across site functions to implement improvements, ensuring compliance with URS through PQ and maintaining validated state across lifecycle.

You will develop protocols, review reports, and participate in audits. The position is fully site-based with strong emphasis on real-time collaboration, accuracy,

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

GMP experience

Validation methodologies

Risk-based approach

Regulatory understanding

Educación

Degree in engineering fields

Herramientas

Kneat GX

Trackwise

Descripción del empleo

Lonza Group Ltd. in Singapore Tuas is seeking a Validation specialist to support day-to-day validation activities for facilities, equipment, utilities and systems. The role requires collaboration across site functions to implement improvements, ensuring compliance with URS through PQ and maintaining validated state across lifecycle.

You will develop protocols, review reports, and participate in audits. The position is fully site-based with strong emphasis on real-time collaboration, accuracy,