ALTEN Group
Within 30 years, ALTEN has become a leader in outsourced Engineering and IT Enterprise Services. With 57,000 engineers, ALTEN manages complex, highly technical projects for 6,500 clients across various sectors including industry, services, and telecommunications. We collaborate with key players in Aeronautics & Space, Defence & Naval, Security, Automotive, Rail, Energy, Life Sciences, Finance, Retail, Telecommunications, and Services sectors.
Since 2005, ALTEN Switzerland, with 450 employees, has been a reference partner in Engineering services for 100 leading companies. Our activities cover strategic areas in Life Sciences, Engineering, and IT Services within the Swiss market.
Position: Qualification/Validation Specialist
Responsible for qualification and validation activities related to production equipment, utilities, HVAC, environment, and cleanroom.
Responsibilities include:
1. Performing qualification phases in accordance with global and local policies, procedures, legal requirements, and regulatory standards.
2. Maintaining and establishing Qualification Master plans for ongoing projects.
3. Planning, coordinating, and executing all phases of qualification for GMP manufacturing systems, including Qualification plans, FMEA, DQ, IQ, OQ, PQ.
4. Preparing, reviewing, and approving technical and GMP documentation (URS, impact/risk assessments, Master plans, qualification reports).
5. Coordinating and executing FAT/SAT and commissioning activities for new manufacturing systems with internal and external partners.
6. Overseeing external suppliers and activities.
Requirements:
* GMP knowledge is essential.
* Master’s degree in pharmaceutical, biotech, or related fields.
* Minimum of 5 years of experience in qualification and validation.
* Languages: English required; proficiency in French and/or German is preferred.
What We Offer
At ALTEN, we provide job security through permanent contracts and the opportunity to work with prestigious clients. Our global presence offers both national and international business opportunities. We operate in a highly innovative market, keeping you at the forefront of technology and enabling you to be a pioneer in your field. We also offer targeted training, workshops, and certifications to enhance your skills and support your participation in groundbreaking projects.
Join us now and be part of our exciting journey. We believe in growing together!
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