Qualification & Validation Engineer – Life Sciences (DE)

ALTEN Group

Within 30 years, ALTEN has become leader in both outsourced Engineering and IT Enterprise Services. ALTEN, composed of 57,000 engineers, carries out complex and highly technical projects throughout the value chain of 6,500 clients, the most prestigious companies in all sectors of industry, services and telecommunications. We work with key actors in the Aeronautics & Space, Defence & Naval, Security, Automotive, Rail, Energy, Life Sciences, Finance, Retail, Telecommunications and Services sectors.

ALTEN Switzerland

Since 2005, with 450 current employees, ALTEN Switzerland is a reference partner in providing Engineering services to 100 world leading companies. ALTEN Switzerland’s activities cover all the main strategical areas of the Swiss market in Life Sciences, Engineering & IT Services.

• Person in charge of Qualification/Validation activities: production equipment and / or utilities & HVAC, environment, cleanroom.
• Qualification phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities.
• Qualification Master plans are up to date and established for all ongoing projects.
• Plan, coordinate and execute all phases for qualification of GMP manufacturing systems including but not limited to, Qualification plans, FMEA, DQ, IQ, OQ, PQ.
• Prepare, review and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification documentation).
• Coordinate and execute FAT/SAT, commissioning activities for new manufacturing systems in collaboration with internal and external partners.
• Coordination and oversight of external suppliers.

• Must have : GMP knowledge
• Must have : Bachelor / Master’s degree in pharmaceutical or biotech related industries.
• Above 3 years of experience in qualification and validation
• Languages: English and/or German
• On-site work in cities: Bern, Zurich, Basel, Schaffhausen

What we offer you

At Alten, we offer you the security of a permanent contract while also giving you the liberty to work with multiple prestigious clients. With the luxury of having a wide range of offices around the world, we are in a unique position to provide you with the freedom to experience national and international business opportunities. Thus, we function in a highly innovative market, always being up to date with the latest technologies and making you a pioneer in your field. Therefore, we offer our employees sought-after trainings and workshops ranging from hard to soft skills and providing you with certificates that will further increase your qualifications, enabling you to participate in ground-breaking projects.

Apply now and be a part of our amazing journey. We believe in growing together!