LifeScience Quality & Validation Lead

About the role

As a LifeScience Quality & Validation Lead you will ensure the quality, compliance and performance of Alfa Laval’s Life Science systems throughout the product lifecycle, from new product development to maintenance.

Key responsibilities

• Create and maintain validation documentation, SOPs, work instructions, test and qualification protocols (CSV, FAT, IQ, OQ).
• Manage validation‑related change control activities across development, maintenance projects and software testing.
• Define requirements for software, components, validation and testing in collaboration with R&D, Quality and other stakeholders.
• Ensure alignment with industry standards, GMP requirements and pharmaceutical customer expectations.
• Lead internal, external and customer audits, identify deviations and drive improvement actions.
• Conduct risk assessments and define Quality & Validation strategies aligned with the product roadmap.

Required profile

• Collaborative professional who can communicate complex topics clearly and build effective relationships.
• Curious, structured and solution‑oriented, taking ownership of high‑quality results.
• At least five years of experience validating complex systems in Life Science or pharmaceutical industry.
• Strong knowledge of GMP, pharmaceutical compliance and relevant regulations.

Required skills

• Computerized System Validation (CSV).
• Risk assessment and risk‑based validation approaches.
• Qualification and testing activities such as FAT, IQ and OQ.
• Creation of validation documentation, SOPs and test protocols.