“Small Molecules Technical Development” (PTDC) brings a broad range of experience across drug substance (DS), drug product (DP), analytical sciences and manufacturing science & technology, and collaborates closely with key partners in the departments Research and Early Development (pRED / gRED), Small Molecules Commercial Manufacturing (PTC) and Global Technical Development (PTD). We are responsible for late stage technical development of our small molecules (SM) pipeline, manufacture of DS and DP for clinical studies across the SM manufacturing network.
In PTDC we transform synthetic molecules into medicines. We develop robust, cost-efficient manufacturing processes while delivering clinical supplies and we build knowledge through innovation and continuous improvement in an environment of collaboration.
The Lifecycle Management Team is responsible for new investments and changes related to systems and facilities in our technical R&D drug product and drug substance areas.
As the Technical Project Coordinator, your key responsibilities are:
- Coordination of projects across all phases of the lifecycle (e.g. planning, realization commissioning and decommissioning) of systems and facilities in close collaboration with customers and engineering
- Definition of requirements and preparation of appropriate documentation together with equipment owner for new systems and facilities
- Organization of trainings and instruction for users
- Submission and tracking of equipment change control in TrackWise
- Represent Lifecycle Management topics as Subject Matter Expert (SME) during health authority inspections and audits
- Assure the contacts and the information exchange with internal (e.g. equipment owner, equipment operators, planning group,) and / external customers (e.g. workshop, engineering)
- Drive optimization, standardization and harmonization of the existing processes, tools and SOPs of the Lifecycle Management team in alignment with key partners
Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies and where a job title is not considered the final definition of who you are, but the starting point.
In addition, you bring the following qualifications:
- Qualification from a university of applied sciences or college of higher education or apprenticeship with supplementary training
- At least 3 years operational experience in a GMP area (Drug Product manufacturing and/or development) within the pharmaceutical/biopharmaceutical business environment
- Technical background regarding new installation and modification projects of drug product equipment including interaction with Engineering, workshop and equipment suppliers
- Experience with health authority inspections and audits would be appreciated
- Great teammate with confirmed ability to build constructive and effective relationships
- Good verbal and written interpersonal skills including communication skills in German and English
Have we sparked your interest? Apply now!
Get in touch with the Recruiting Team Switzerland +41 61 682 25 50.
Roche is an equal opportunity employer.
Manufacturing, Manufacturing > Production Engineering