Process Validation Expert (all genders)

Merck Group Alle Jobs anzeigen

  • Aubonne, Waadt
  • Unbefristet
  • Vollzeit
  • 14 Tage her
Work Your Magic with us!Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.As a member of the Process Validation group within the MSAT (Manufacturing Sciences and Technologies) team, you will be involved in activities related to the validation of Biotechnological manufacturing processes (Drug Substance, Drug Product, and Finished Product).Process manufacturing validation activities are performed in collaboration with various site teams (Production, Quality, Engineering, Supply, etc.) and encompass defining process validation strategies, tracking validation testing, compiling data, analysing results, conducting investigations, and drafting validation documents.Your role:
  • Define validation strategies, in collaboration with the project manager and other site departments, for New Product Introductions (NPI), Technology Transfer (TT), manufacturing process validation, or changes affecting marketed products.
  • Bring the required level of expertise to the project team by identifying risks, potential optimizations, the most relevant technical choices, and operational constraints.
  • Coordinate on-site process validation activities in collaboration with impacted departments.
  • Ensure timely preparation of required documents (plans, protocols and reports, risk analyses, etc.) as defined in the project plan.
  • Train production teams on validation protocols.
  • Supervise and support the execution of process validation protocols, including outside of standard hours if necessary.
  • Ensure appropriate documentation and data management using the relevant computer systems, including quality management software.
  • Compile data / Collect data from production.
  • Interpret results obtained in the context of process validation testing.
  • Manage deviations and validation investigations in the appropriate system.
  • Keep validation procedures and standards up to date and optimize them according to requirements and evolving standards.
  • Actively contribute to a culture of integrity and professional ethics.
  • Ensure compliance with legal, regulatory, and corporate directives.
Your profile:
  • Master of Science in Biotechnology / Life Sciences / (Bio)Chemistry or equivalent degree, or at least 5 years of professional experience in biotechnology
  • Demonstrated experience in process validation. Strong experience in Drug Substance processes is an asset
  • Strong analytical and synthesis capabilities
  • Excellent writing skills
  • Proficiency with GMP/GDP and good knowledge of health authority requirements
  • Organized, persistent, and resilient
  • Collaborative mindset and ability to work well in a team, plus the ability to work independently and autonomously
  • Very good communication skills
  • Aptitude for digital tools
  • Interest in statistical analyses
  • Fluent in French and English (spoken and written)
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

Merck Group