MES Process Owner (m/w/d) Engineering, Science and Technology Kaiseraugst

at  Roche

Kaiseraugst, AG, Switzerland -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate28 Dec, 2024Not Specified03 Oct, 2024N/AEnglish,Trello,Matrix,Team Spirit,It,Veeva,Presentation SkillsNoNo
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Description:

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position
At the heart of progress is innovation, driving us to push boundaries, advance science, and ensure everyone today and for future generations has access to healthcare. We strive to build a world where we can all spend more time with the people we love. This is what defines us at Roche.
With 1,400 employees, the Roche Kaiseraugst Site ensures uninterrupted patient care with high-quality medicines. Known for the highest standards in pharmaceutical manufacturing, the largest and most innovative packaging center, and the distribution of products to over 120 countries, we take pride in our global impact.
Our Engineering, Science, and Technology (ES&T) support function provides expertise to our value streams (Production and Logistics), ensuring that we meet regulatory requirements throughout the lifecycle of our products. By maintaining, validating, and harmonizing processes, we contribute to the successful operation of the Kaiseraugst site through scientific and technical competence, forward-thinking and a commitment to continuous improvement.

ADDITIONALLY, YOU BRING THE FOLLOWING SKILLS AND COMPETENCIES:

  • Experience in GMP environments with a deep understanding of quality systems and efficient implementation of GMP requirements
  • Familiarity with internal GMP audits or inspections from health authorities
  • Previous experience with MES systems (e.g., PharmaSuite, PasX, Syncade etc.)
  • Strong IT skills, with experience in tools like Trello and Veeva being a plus
  • A team player who is comfortable working in matrix and self-organized teams
  • High team spirit, solution orientation, and a collaborative working style
  • Proficiency in both German and English is required
  • Strong communication and presentation skills tailored to diverse audiences
  • Join us in driving progress and shaping the future of healthcare
    Who we are
    At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
    Roche Kaiseraugst is a cornerstone of Roche’s global production and logistics network. It employs some 1900 people out of the 10,700 employees at our Basel/Kaiseraugst site and is Roche’s largest and most innovative packaging facility worldwide. Read more.
    Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.
    We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

Responsibilities:

  • Conceptual responsibility for the continuous development of the MES process landscape
  • Leading process optimization projects using statistical and digital applications, with the aim of continuously improving production workflows
  • Participating and contributing to various expert forums
  • Preparing and updating GMP documentation (e.g., SOPs, rationales, risk analyses, test plans, and reports)
  • Managing system changes and deviations in our QMS system
  • Representing technical areas during audits and inspections
  • Collaborating closely with other departments such as Engineering, Manufacturing IT, Materials Management, Value Streams, and Quality Assurance due to the interdisciplinary nature of this role


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Information Technology/IT

Pharma / Biotech / Healthcare / Medical / R&D

Software Engineering

Graduate

Proficient

1

Kaiseraugst, AG, Switzerland