Vacant job

Join Sweden's most experienced team of Validation Leaders - At Knightec Group!

We offer you a unique opportunity to be part of a workplace where community, development, and knowledge sharing are in focus. At Knightec Group, you will have the chance to work in teams with both junior and senior colleagues – we support each other in our daily work and make knowledge exchange a natural part of our everyday life.

Your role with us

As a validation leader, you will lead and drive validation work within Life Science projects of various sizes and complexities. You will ensure that processes, systems, and equipment meet regulatory requirements and standards. By working closely with both clients and the internal team, you will contribute to high quality at all levels.

Specific tasks

• Lead and coordinate validation work for equipment, processes, and computer systems
• Conduct risk analyses (FMEA, HACCP) and develop validation strategies
• Plan, review, create, and approve validation documentation, including URS, IQ, OQ, and PQ
• Ensure that validation activities meet regulatory requirements (GMP, FDA, ISO standards)
• Collaborate with clients and project teams to ensure timelines and project goals are met

Technical requirements and qualifications

• Experience in validation within Life Science, e.g., pharmaceutical, biotechnology, or medical technology industries
• Good knowledge of regulatory requirements and standards such as GMP, EudraLex Volume 4 Annex 15, and ISO 13485
• Experience in creating and reviewing validation documentation, including URS, IQ, OQ, DQ, and PQ
• Knowledge of risk analysis methods (e.g., FMEA) and the ability to apply them in practice
• Fluent in Swedish and English, both spoken and written

What you get with us

Experienced colleagues and strong community – You will work alongside some of the most experienced validation leaders in the industry. Here, teamwork is more than just words – we work closely together and support each other at all stages of the projects.

Personal development and career opportunities – With us, there is room for you to develop, whether you want to deepen your expertise in a specific niche or take the next step as a leader.

Knowledge sharing in focus – We learn from each other and share our experiences. Through workshops, mentorship, and daily collaboration, we develop together.

Benefits and flexibility – We know that life is more than work. With us, you will enjoy a flexible work environment and benefits designed to create a balance between work and leisure.

Who are you? We are looking for someone with experience in validation work within Life Science who is ready to take the next step in their career. You thrive in a team environment where collaboration and knowledge exchange are key to success. Your communication skills and analytical approach to tasks make you a valued colleague and leader.

Does this sound interesting? Then it’s time to take the step and become part of Knightec Group! We look forward to meeting you and telling you more about our exciting projects and our culture. Together, we continue to be Stockholm's most experienced and engaged team of validation leaders.

An exciting journey with Knightec Group

At Knightec (https://knightec.se/), we are now joining forces with our sister company Semcon (https://www.semcon.com/sv) to form Knightec Group. Together, we will become the leading player in Northern Europe in product and digital service development – how cool is that? Our joint offering will be both broader and deeper, allowing us to take on large, strategic customer projects at the highest level of innovation and complexity. For our employees, this means fantastic opportunities for skill development and career paths. Does this sound like the place for you? Join us on this exciting journey!