Associate Manager, Engineering Validation

About the role

Lonza is hiring an Associate Manager, Engineering Validation for its site in Singapore Tuas. The role manages the validation of facilities, equipment and utilities and ensures the site's validation lifecycle program complies with regulatory requirements. It provides leadership and oversight of routine operational and administrative activities. This is a fully site-based position.

Key responsibilities

• Supervise and manage day-to-day validation activities in line with approved validation SOPs, plans and policies.
• Take part in reviewing and approving validation SOPs and plans to support the Validation Strategy set out in the Validation Master Plan.
• Manage the deployment of internal and external validation resources to meet department and project goals.
• Liaise with system owners, the quality unit and other departments, including clients, so that the scope, execution and reporting of the validation program meet their expectations.
• Plan and manage on-the-job training, regularly review training needs and identify gaps and improvements.
• Take part in regulatory inspections and client audits and respond to validation-related issues.
• Plan, schedule and manage validation efforts for large-scale change projects in line with cGMPs.
• Oversee validation deviation investigations and take part in resolving deviations and corrective and preventive actions.

Required profile

• Degree in Engineering, Life Sciences or a related discipline, or work experience in a pharmaceutical validation role.
• People management experience, with leadership and managerial responsibilities for direct reports.
• Knowledge of cGMP.
• Strong problem-solving, troubleshooting and analytical skills.
• Ability to work cross-functionally and manage multiple priorities.

What we offer

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• Compensation programs that recognise high performance.
• A range of benefits depending on role and location.