Software Validation Manager (gn)

Formycon is an international leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. With an experienced team comprised of more than 200 highly skilled professionals, the company is able to span the entire value chain of biosimilar drug development, from market analysis and target definition by protein analytics, to the development of production processes, to clinical trials and the regulatory approval process. Our focus is on treatments in ophthalmology and immunology as well as for other key chronic diseases. Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines.

To support our team in Martinsried near Munich, we are looking for suitable candidates for this full-time and permanent position, to begin work as soon as possible.

Ihre Aufgaben

• Ensuring GxP-compliant operation of new and already implemented software solutions by planning (re-)validation measures, creating and providing validation documentation

• Preparation, execution and finalization of validation documentation (e.g. validation plan, URS, FS, risk analysis, IQ, OQ)

• Carrying out validation workshops with the specialist departments

• Monitoring, moderation and processing of change, CAPA and deviation measures in the IT and CSV area

• Support of subject matter experts during internal and external audits and active participation in audits

• Coaching the departments in the creation of validation documentation

• Supporting IT with infrastructure qualification

• Close cooperation with the Digitalization, IT and QM departments

• Optimization and (re-)design of business processes in context of digitalization projects

• Driving project progress and securing quality for project deliverables

Ihr Profil

• Completed studies (Master's degree, diploma) in the field of natural sciences, business administration or computer science or a comparable degree

• At least 2 years of professional experience with software validations as a validation lead in a GxP-regulated environment, preferably with CSV projects in the pharmaceutical environment

• Experience in infrastructure qualification is an advantage

• Very good GxP knowledge including data integrity requirements

• High IT affinity (software and IT infrastructure)

• Certification as a software tester and ideally a certification in requirements management is desirable, but not a must

• Very good written and spoken English skills

• Business Professional German language skills

• High sense of responsibility and independent working style

• Very good team player, result-oriented and proactive

• Creativity and enthusiasm for working in a dynamic, fast-growing biopharmaceutical company

Wir bieten Ihnen

• Flexible working time

• Hybrid work

• 30 days paid vacation

• Formycon pension

• Group accident insurance

• Formycon card

• Continuing education offers

• Team spirit, great working atmosphere and much more!

  Bring us your skills and energy, and shape your own career in a stimulating and open work environment. We are looking for highly motivated individuals who are ready to take on new challenges with enthusiasm and personal commitment. Working at Formycon means being part of a smart, innovative team with minimal hierarchy and opportunity to share your own ideas.