MSAT PPS Engineer (m/f/d) - GxP/GDP/highly regulated production/process management/Agile/English and German

Project:
For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a highly qualified MSAT PPS Engineer ( (m/f/d).

Background:
The Manufacturing Science & Technology Team (MSAT) is working in an agile Framework. We are shaping and continuously improving the manufacturing of highly integrated sensors and cartridges (S&C). Our service scope starts with input to first concept ideas, continues through a fast and effective design transfer from development into routine manufacturing and finally ensures a robust and sustainable product care phase over the entire life cycle. Organized in Sub-Networks, Squads are at the center of our agile Organization and are supported by competencies organized in chapters. With this setup, we adapt to changing priorities and support the dynamic needs within the S&C organization.

We foster agile ways of working, build trust as strategic business partners and help to break down silos between areas by: driving collaboration inside and outside of Operations, leveraging continuous learning with an extraordinary team in a rewarding environment, developing our capabilities to contribute more to the team and the organization, mastering complexity with unique expertise by taking data driven decisions and implementing standardized digital solutions, embracing new technologies to enable tailored development and fast market access with our global partners and delivering our contributions in a way that lives up to our commitments to each other and our values: Courage, Transparency, Open Mindedness and Can Do Attitude. This all leads to developing and producing highly integrated, quality S&C products that serve our customers' needs throughout the entire life cycle.

The perfect candidate has an educational background within Engineering or Life Sciences as well as experience in a highly regulated production environment. First experience with GxP is required and experience with process management is of advantage.

Tasks & Responsibilities:
* Analysis, documentation and review of sensor QC results
* Routine Analysis, documentation and review of sensor QC results
* Monitoring, analysis and handling of issues occurring during release testing
* Preparation and execution of deviation notifications, variances, changes, out of specifications and CAPAs
* Drive and lead QC related topics and initiatives
* Definitions of Working Instructions and general documents, improvement of the QC processes and tools
* Communication and coordination with internal and external partners (eg production, quality assurance, engineering support and development)

Must Haves:
* Education in Engineering, natural sciences or related field
* First experience in a highly regulated production environment
* First experience GxP, especially with good documentation practice
* Experience in process management (Change, deviation management, product risk analysis) is of advantage
* Interest in agile methodologies or project management techniques and in delivering on targets
* Autonomous and flexible team player with the ability for self reflection. In a Matrix organization you recognize how to optimize your and the organization's impact by living a culture of accountability and shaping the working model in alignment with your interfaces
* Ability to deal with difficult situations and resolve conflicting perspectives by an open and solution oriented mindset while inspiring others with servant leadership style as well as your outstanding technical expertise
* Thinking strategically and set concrete objectives with an entrepreneurial mindset showing excellent budget and timeline ownership
* Fluent in both English and German

Nice to Have:
* Database handling (SQL, Snowflake) and experience with software projects
* Experience with statistical analysis
* Coordinative or lead experience in project or production environment
* Knowledge of lean methods
* Beneficially, you have professional experience in a highly regulated industry, ideally in the pharmaceutical or medical sector.

Reference Nr.: 923352SDA
Role: MSAT PPS Engineer (m/f/d)
Industrie: Pharma
Workplace: Rotkreuz
Pensum: 80-100% (Home Office: max. 40-60%)
Start: 01/06/2024
Duration: 12++ unlimited
Deadline: 26.05.2024

If you are interested in this position, please send us your complete dossier via the link in this advertisement.

About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.
We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.