LifeScience Quality & Validation Lead

Alfa Laval Mid Europe GmbH; Stockholms kommun; On-site; SEK 900,000 - 1,200,000; Full time

Job summary

Alfa Laval is seeking a LifeScience Quality & Validation Lead to ensure quality, compliance and performance of Life Science systems throughout the product lifecycle. You will develop validation documentation, lead audits, and drive risk-based validation strategies across development and maintenance projects.

You will collaborate with R&D and Quality to align with GMP standards, participate in testing at facilities and with subcontractors, and mentor teams in best practices and regulatory

Qualifications

• Minimum five years' experience validating complex Life Science/pharma systems.
• Strong GMP/pharma compliance knowledge.
• Familiarity with computerized system validation (CSV).
• Experience with risk-based validation approaches.
• Experience with FAT, IQ, OQ activities.
• Excellent English communication.

Responsibilities

• Create and maintain validation documentation, SOPs, 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 with R&D, Quality and stakeholders.
• Lead internal, external and customer audits, identifying deviations and actions.
• Lead risk assessments and define Validation strategies across the product lifecycle.

Skills

Validation

Quality Assurance

GMP Compliance

CSV

Risk Assessment

Audits

Communication

Job description

Every day, we get opportunities to make a positive impact—on our colleagues, partners, customers, and society. Together, we’re pioneering the solutions of the future and unlocking the full potential of precious resources. Trusted to act on initiative, we challenge conventional thinking to develop world-leading technologies that inspire progress in vital areas, including energy, food, water, and shipping.As we push forward, the innovative, open spirit that fuels our 140-year-old start-up culture and rapid growth also drives our personal growth. So, as we shape a more resourceful, less wasteful world, we build our careers too.About the roleAs a LifeScience Quality & Validation Lead, you will play a key role in ensuring the quality, compliance and performance of Alfa Laval’s Life Science systems. You will own and develop Quality & Validation processes our R&D Life Science systems portfolio throughout the entire product lifecycle—from New Product Development to Existing Product Development.Your mission will be to demonstrate that our Life Science systems and related processes meet defined requirements, industry standards and customer expectations. You will contribute from the early stages of development through product maintenance, working with planning, requirements definition, documentation, testing, qualification and follow-up.Working closely with R&D and other stakeholders, you will help ensure the quality of our products and drive continuous improvement across our processes and solutions.Key responsibilitiesCreate and maintain validation documentation, SOPs, work instructions, test protocols and qualification protocols, including CSV, FAT, IQ and OQ.Manage validation-related change control activities across development and maintenance projects, software activities and testing assignments.Define requirements for software, components, validation and testing in collaboration with R&D, Quality and other key stakeholders.Ensure alignment with relevant industry standards, GMP requirements and pharmaceutical customer expectations.Participate in testing and verification of machine functionality at R&D facilities, Alfa Laval manufacturing sites and subcontractors.Lead internal, external and customer audits, identifying deviations, improvement opportunities, gaps and required actions.Lead risk assessments and define Quality & Validation strategies throughout the product lifecycle, aligned with the Life Science product roadmap.Drive continuous improvement, promote best practices and share knowledge through training, demonstrations, conferences and stakeholder activities.Who you areYou are a collaborative and communicative professional who enjoys working with colleagues across different functions, locations and levels of responsibility. You can explain complex topics clearly, both verbally and in writing, and build effective working relationships with internal and external stakeholders.You are curious, structured and solution oriented. You see challenges as opportunities to improve, anticipate potential consequences and take ownership of delivering high-quality results on time.What you knowAt least five years of experience validating complex systems in the Life Science or pharmaceutical industry.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, such as FAT, IQ and OQ.An understanding of relevant Life Science regulations, standards and industry guidelines.Excellent communication skills in English, both written and spoken.What’s in it for you?This is an opportunity to develop as a Subject Matter Expert and help strengthen Alfa Laval’s ability to meet industry regulations and customer expectations. You will have a central role in shaping robust, compliant and reliable Life Science systems while influencing the development of our products, processes and ways of working.You will work with talented colleagues across the organization and have the opportunity to make a tangible impact throughout the product lifecycle.For more information, please contactFabio Gillué Tomás, Manager Smart Separation Systems Design & Development, [e-mail] García Moguel, Talent Acquisition Partner, [e-mail] informationAxel Schäring, Akademikerna, [e-mail] Jansson, Unionen, [e-mail] review applications continually so please send in yours as soon as possible and not later than November 1st, 2026.Please note that, in compliance with GDPR, we cannot accept applications submitted via email.As part of Alfa Laval commitment to a safe and healthy workplace, alcohol and drug testing is applied during the preemployment process.#LI-RG1