Senior Life Science Quality & Validation Lead

Alfa Laval; Stockholms kommun; On-site; SEK 900,000 - 1,100,000; Full time

Job summary

Alfa Laval seeks a Life Science Quality & Validation Lead to secure quality, compliance and performance of Life Science systems across the full product lifecycle—from development to maintenance. You will own validation programs, risk assessments and qualification activities, collaborating with R&D, QA and manufacturing to meet industry standards.

Lead audits, drive continuous improvement, and ensure alignment with GMP requirements and customer expectations while promoting best practices

Qualifications

• At least five years of experience validating complex Life Science/pharma systems.
• Strong knowledge of GMP and pharmaceutical compliance requirements.
• Familiarity with computerized system validation (CSV).
• Experience with risk assessments and risk-based validation approaches.
• Knowledge of qualification and testing activities (FAT, IQ, OQ).
• Understanding of Life Science regulations and industry guidelines.
• Excellent English communication, both written and spoken.

Responsibilities

• Create and maintain validation documentation, SOPs, work instructions, test protocols and qualification protocols (CSV, FAT, IQ, OQ).
• Manage validation-related change control across development and maintenance projects.
• Define requirements for software, components, validation and testing in collaboration with R&D and Quality.
• Ensure alignment with GMP requirements and customer expectations.
• Participate in testing and verification at R&D facilities, Alfa Laval sites and subcontractors.
• Lead internal, external and customer audits, identify deviations and actions.
• Lead risk assessments and define Validation strategies across the lifecycle.
• Drive continuous improvement and share knowledge via training and stakeholder activities.

Skills

GMP knowledge

CSV familiarity

Risk assessment experience

Qualification & testing (FAT IQ OQ)

English communication

Job description

Alfa Laval seeks a Life Science Quality & Validation Lead to secure quality, compliance and performance of Life Science systems across the full product lifecycle—from development to maintenance. You will own validation programs, risk assessments and qualification activities, collaborating with R&D, QA and manufacturing to meet industry standards.

Lead audits, drive continuous improvement, and ensure alignment with GMP requirements and customer expectations while promoting best practices