Qualification & Validation Engineer - Life Sciences (DE)
ALTEN is a leader consultancy company divided in 3 different business units: IT, Engineering and Life and Science, operating in more than 30 countries worldwide by now. We have around 54,000 employees (88% engineers) working with our clients. ALTEN group has 6,500 Clients in various sectors such as pharmaceutical sector, aerospace, telecoms, finance, energy, automotive, public sector and more... As a company we support them with their expertise. In ALTEN Switzerland we have 450 Employees and 100 clients.
Are you passionate about technology and like to take on complex technical challenges? Do you want to work in exciting projects at renowned clients? At ALTEN we believe that knowing and meeting the expectations of our consultants is a key factor in our success. Our consultants make the difference. Do you want to make the difference too?
- 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
