Validation Lead

Novartis Pharma Schweiz; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

Novartis is seeking a Validation Specialist to support site validation planning and lifecycle activities in a biopharmaceutical manufacturing environment in Singapore. You will maintain master plans for process, cleaning, and shipping validation, ensure OPV controls, and collaborate across functions to ensure risk is managed and documentation is inspection-ready.

Responsibilities include authoring validation protocols and reports, reviewing Master Batch Records, managing deviations, and

Qualifications

• University degree (BSc, MSc) in Chemistry, Biologics, Pharma / Chemical Engineering or equivalent.
• Strong working knowledge of quality systems and regulatory requirements across multiple health authorities.
• 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 processes and ongoing verification activities.
• Support process validation lifecycle activities by ensuring a state of control is maintained through ongoing process verification (OPV). Ensure that appropriate variables are identified for on-going monitoring as a contributor to quality risk management activities.
• Author and review process, process, shipping and or cleaning validation protocols & reports, and subsequent ongoing / continuous verification protocols & reports.
• Support execution of validation activities at the shop floor and for KPI reporting.
• Reviews Master Batch Records and associated change controls. Confirm revalidation need based on technical changes.
• Maintain all activities and projects under own responsibility in an inspection ready status.
• Provides technical expertise (and may facilitate) pre-validation risk assessments using risk management tools.
• Ensure that all Site validation activities are performed in line with current Novartis requirements and cGMP, manage deviations and prevention of reoccurrence.
• Work with development organization for technical transfers and new product launches to ensure knowledge transfer, control strategies are appropriate, risks analyzed and controlled.
• Participate in pre-validation activities and risk assessments to ensure the success of commercial process validation.

Job description

• Support site validation planning by writing and maintaining master plans for process, cleaning, shipping processes and ongoing verification activities (as applicable).
• Support process validation lifecycle activities by ensuring a state of control is maintained through ongoing process verification (OPV). Ensure that appropriate variables are identified for on‑going monitoring as a contributor to quality risk management activities.
• Author and review process, process, shipping and or cleaning validation protocols & reports, and subsequent ongoing / continuous verification protocols & reports.
• Support execution of validation activities at the shop floor and for KPI reporting.
• Reviews Master Batch Records and associated change controls. Confirm revalidation need based on technical changes.
• Maintain all activities and projects under own responsibility in an inspection ready status.
• Provides technical expertise (and may facilitate) pre‑validation risk assessments using risk management tools. Work collaboratively and cross functionally to help ensure that process risks are analyzed, appropriately controlled and appropriately documented.
• Ensure that all Site validation activities are performed and are in line with the current Novartis requirements and cGMP, manage deviations associated with process validation and makes recommendations for deviation resolution as well as prevention of reoccurrence.
• Work in close collaboration with development organization (or sending site) for technical transfers and new product launches to ensure that knowledge is transferred, control strategies are appropriate, risks are analyzed and controlled and to ensure that commercial processes are validation ready.
• Participate in pre‑validation activities and risk assessments to ensure the success of commercial process validation.
• University degree (BSc, MSc) in Chemistry, Biologics, Pharma / Chemical Engineering or equivalent.
• Strong working knowledge of quality systems and regulatory requirements across multiple health authorities.
• 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).

Major Accountabilities

• Support site validation planning by writing and maintaining master plans for process, cleaning, shipping processes and ongoing verification activities (as applicable).
• Support process validation lifecycle activities by ensuring a state of control is maintained through ongoing process verification (OPV). Ensure that appropriate variables are identified for on‑going monitoring as a contributor to quality risk management activities.
• Author and review process, process, shipping and or cleaning validation protocols & reports, and subsequent ongoing / continuous verification protocols & reports.
• Support execution of validation activities at the shop floor and for KPI reporting.
• Reviews Master Batch Records and associated change controls. Confirm revalidation need based on technical changes.
• Maintain all activities and projects under own responsibility in an inspection ready status.
• Provides technical expertise (and may facilitate) pre‑validation risk assessments using risk management tools. Work collaboratively and cross functionally to help ensure that process risks are analyzed, appropriately controlled and appropriately documented.
• Ensure that all Site validation activities are performed and are in line with the current Novartis requirements and cGMP, manage deviations associated with process validation and makes recommendations for deviation resolution as well as prevention of reoccurrence.
• Work in close collaboration with development organization (or sending site) for technical transfers and new product launches to ensure that knowledge is transferred, control strategies are appropriate, risks are analyzed and controlled and to ensure that commercial processes are validation ready.
• Participate in pre‑validation activities and risk assessments to ensure the success of commercial process validation.

Essential Requirements

• University degree (BSc, MSc) in Chemistry, Biologics, Pharma / Chemical Engineering or equivalent.
• Strong working knowledge of quality systems and regulatory requirements across multiple health authorities.
• 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).

Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.