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Process Monitoring Specialist
A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
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.
Within the Merck-Aubonne Fill & Finish Department, the MSAT-NBEs DP team coordinates all the Drug Products activities to ensure:
- the supply of New Biologic Entities (NBEs) part of Healthcare pipeline (investigational Medicinal Products - IMPs),
- the business continuity and Product-Lifecycle activities on legacy products portfolio, in compliance with specifications, registration and GMP requirements
Evolving in this environment, and with a strong focus on the Product Lifecycle & process validation activities, your role:
- Assure the timely delivery of the CPV documents (plans, PCS, reports) as per project plan,
- Ensure appropriate data management using corresponding IT system, including Statistical & QMS softwares (Discoverant, TrackWise, ManGo),
- Lead weekly meetings and track CPV activities progress, inform about any trend, discrepancy or issue identified,
- Able to prioritize and value simplicity,
- Participate to internal/external audits, as CPV Subject Matter Expert,
- Strongly collaborate in a transversal mode with the different functions and departments from site (Quality, QC, DS Biotech).
Who you are:
- Education in Pharma,Biotech,Biochemistry or Chemistry with statistical background
- Experience in GMP environment suitable
- Experience in the field of data science and data management
- Proactive mindset for identifying processus improvement opportunities and anticipating future challenges or opportunities
- Fluent in French & English, excellent in writing, interpersonal communication, and presentation
- To be part of our future reshaping, experience or knowledge in Process Analytical Technology/Quality by Design, Machine Leaning or Artificial Intelligence is a plus.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!
Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.merckgroup.com/en/company/press-positions.html