LifeScience 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

For more information, please contact Fabio Gillué Tomás, Manager Smart Separation Systems Design & Development, [e-mail]

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 Role

As 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 Responsibilities

• Create 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 Are

You 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 Know

• At 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 contact Fabio Gillué Tomás, Manager Smart Separation Systems Design & Development, [e-mail]

Regina García Moguel, Talent Acquisition Partner, [e-mail]

Union information

Axel Schäring, Akademikerna, [e-mail]

Anders Jansson, Unionen, [e-mail]

As part of Alfa Laval commitment to a safe and healthy workplace, alcohol and drug testingisapplied during the preemployment process.