Validation Leader – Consulting Assignment within Life Science

About the company

We at WeQuel are now looking for a validation leader in Södertälje, where you will become an important part of a project team focusing on validation and qualification within production in Life Science. You will lead and drive the validation work in projects of varying size and complexity and ensure that processes, systems, and equipment meet regulatory requirements and standards. You will work closely with both the customer and the project team and contribute to high quality at all levels.

Your tasks

As a consultant with us, you will have the opportunity to work at one of our customers, which are leading companies within pharmaceuticals and Life Science, where you contribute to delivering safe products and ensuring that projects reach their quality and time goals.

Your tasks

• Management and coordination of verification work for equipment, processes, and computer systems
• Risk analyses (FMEA, HACCP) and development of verification strategies
• Planning, development, review, and approval of verification documentation, including URS, commissioning, DQ, IQ, OQ, and PQ
• Development of test protocols for verification tests of processes, systems, and equipment
• Ensuring that validation activities meet regulatory requirements (GMP, FDA, ISO standards)
• Collaboration with customers and project teams to meet timelines and project goals

You will work in a dynamic environment where you independently lead your work forward while simultaneously collaborating with several contact points within the customer's organization.

Requirements

• Experience in validation or qualification within production in Life Science
• Experience in creating and reviewing validation documentation, including URS, DQ, IQ, OQ, and PQ
• Engineering degree in biotechnology, medical technology, chemical engineering, mechanical engineering, or equivalent
• Fluent Swedish and English, both spoken and written
• Experience and knowledge regarding GAMP 5 and classification of systems
• Good knowledge of regulatory requirements and standards such as GMP, EudraLex Volume 4 Annex 15, and ISO 13485
• Knowledge of risk analysis methods (for example, FMEA) and the ability to apply them in practice
• Structured and communicative, with a desire to lead others
• Problem-solving and accustomed to multiple contact points

What we offer

At WeQuel, you will become part of a consulting team that values people first; we believe that success is created through engagement, collaboration, and development. We offer a flat organization with short decision paths, a strong sense of community, and the opportunity to influence your own development.

Other

Assignment details

• Scope: 100 %
• Remote: 100 % onsite