MSAT (Senior) Process Validation Engineer
Cilag AG, part of Johnson & Johnson Innovative Medicine, is recruiter for a MSAT (Senior) Engineer to be located in Schaffhausen, Switzerland.
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Come and join us to create a future where disease is a thing of the past. Johnson & Johnson Innovative Medicine Schaffhausen Site/Cilag AG is a Launch site for new products with focus on Parenteral Products (e.g., pre-filled syringes and vials).
We belong to the Manufacturing Science & Technology (MSAT) organization for the MTO (Manufacturing and Technical Operations) Large and Small Molecule Manufacturing Platform. We support the Parenteral small and large molecule Filling, visual inspection, device assembly and packaging operations at J&J Innovative Medicine Schaffhausen and currently we are looking for a MSAT (Senior) Validation Engineer (12-24 months) to be based in Schaffhausen, Switzerland to join our team.
Position summary:
You will be the Site MSAT representative on multi-functional teams supporting process validations of automated visual inspection of pre-filled syringes, vials and cartridges as well as device assembly and packaging processes of pharmaceutical products at the Schaffhausen Fill Finish site.
You will provide the following:
- Technical support and leadership to top line growth
- Ensure reliability, compliance & efficiency of product value chains end to end
- Integrate Manufacturing Operations and Pharmaceutical Development in partnership with Product and Customer Management
Principal responsibilities:
- Site MSAT SME for Device Assembly, Packaging and Automated Visual Inspection
- Accountable to meet project timelines during qualification and validation of visual inspection, device assembly and packaging lines and related processes.
- Support validation activities with internal partners as part of multi-functional project teams.
- Deliver on strategic project goals, process improvements and innovation to ensure competitiveness at the pharmaceutical market and with global players.
- Provide Technical Assessments to Change Controls/CAPAs and Deviations.
- Active participation in health authority inspections as Subject Matter Expert.
- Maintain excellent partnership with all business partners.
- Perform statistical analyses on production data.
