Qualification Validation Engineer LIFE SCIENCES

agap2 is a dynamic and rapidly growing company and employs more than 9000 people in 14 European countries. With more than 200 employees in Switzerland we are specialized in Life Science MedTech Pharma BioTech etc. Our offices in Switzerland are located in Basel Zrich and Lausanne

agap2 works successfully in all areas of the product life cycle including Research & Development Quality Management Regulatory Affairs Production and Commercialization.

agap2 offers a permanent contract for highly qualified specialists with a background in engineering and life sciences for operative industry projects.

Tasks

• Qualification and Validation activities for production equipment and/or processes
• Creation of qualification plans/reports for DQ IQ OQ PQ SAT FAT
• Creation of specifications (URS) and risk analyses (FMEA)
• Creation and review of the Validation Master Plan (VMP)
• Ensuring quality standards in the area of equipment/plant construction
• Application of appropriate quality standards (GMP)
• Innovative & Continuous Improvement
• Operational handling of Change Controls CAPAs and NonConformities
• Internal and external stakeholder management

Requirements

• Bachelor Masters diploma Ph.D. or equivalent in biotechnology pharmaceutical medical technology or related field
• A minimum of 1 year of extensive work experience in the CQV (Commissioning Qualification & Validation) sector
• Knowhow of Qualification & Validation requirements
• Professional experience in a GMPregulated environment
• Fluency in English and German

Benefits

You will have a technical manager at your side who will accompany support and prepare you for the next step of your career at agap2. Furthermore you can expect a collegial team in a dynamic working atmosphere extensive development opportunities and the prospect of quickly taking on responsibility and actively shaping the future of the company.