Process & Cleaning Validation Lead

novartis singapore; Singapore; On-site; SGD 90,000 - 120,000; Full time

Job summary

Novartis Singapore is seeking a qualified professional to manage and execute process, cleaning, and shipping validation activities in a GMP environment at the Tuas South site. The role ensures ongoing verification and compliant documentation, aligning with global regulatory expectations.

You will collaborate across functions to maintain inspection readiness, review master records, and drive risk-based improvements.

Qualifications

• University degree (BSc, MSc) in Chemistry, Biologics, Pharma / Chemical Engineering or equivalent.
• 2-4 years of experience in biopharmaceutical environment within a manufacturing site.
• Experience in executing process and/or cleaning validation and in reviewing and writing technical reports.
• Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions).

Responsibilities

• Support site validation planning by writing and maintaining master plans for process, cleaning, shipping and verification activities.
• Support process validation lifecycle activities with ongoing process verification and monitoring.
• Author and review validation protocols & reports for process, shipping and cleaning.
• Support execution of validation activities on the shop floor and KPI reporting.
• Review Master Batch Records and change controls; confirm revalidation need based on changes.
• Maintain activities and projects in inspection-ready status.
• Provide technical expertise and facilitate pre-validation risk assessments.
• Ensure site validation activities comply with current Novartis requirements and cGMP; manage deviations.
• Collaborate with development organization for technical transfers and launches to ensure validation readiness.
• Participate in pre-validation activities and risk assessments.

Education

Bachelor/Master in Chemistry or Biologics/Pharma/ Chemical Engineering

Job description

Novartis Singapore is seeking a qualified professional to manage and execute process, cleaning, and shipping validation activities in a GMP environment at the Tuas South site. The role ensures ongoing verification and compliant documentation, aligning with global regulatory expectations.

You will collaborate across functions to maintain inspection readiness, review master records, and drive risk-based improvements.