Senior Engineer MSAT Bio DP, 2-year limited contract

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Job Function:
Supply Chain Engineering

Job Sub Function:
Process Engineering

Job Category:
Scientific/Technology

All Job Posting Locations:
Schaffhausen, Switzerland

Job Description:

We are searching for the best talent for Senior Engineer, MSAT Biotherapeutic Drug Product (24 month fixed-term contract)! This hybrid position will be located in Schaffhausen, Switzerland.

As a member of the Site Technical Owner (STO) Team, the Senior MSAT Bio DP Engineer will serve as the Site MSAT representative on multi-functional teams and is responsible for leading the reliability of product processes of commercial product and new product introductions (NPI's) for biologic parenteral liquids, suspensions, and lyophilized products at the Schaffhausen Fill Finish site.

This involves collaborating in multi-functional teams within the site and exchanging knowledge with other locations worldwide.

They will provide technical support and leadership to top-line growth, as well as ensure reliability, compliance, and efficiency of product value chains end-to-end (E2E).

The Site MSAT Rep will also integrate Manufacturing Operations and Pharmaceutical Development, in partnership with Product and Customer Management.
Responsibilities:


* Serve as Site Technical Owner for specific commercial drug products in Life Cycle Management


* Own and coordinate validation activities with internal partners


* Lead or contribute to multi-functional project teams, providing technical guidance and coordinating activities to meet quality, timeline, and compliance objectives


* Implement process capability, quality, and cost improvement changes


* Support E2E technical guidance for product lifecycle activities, including Continued Process Verification (CPV) trending, change implementation, and continuous improvement


* Provide technical feedback and assessments for deviations, investigations, CAPAs, and change controls related to drug product manufacturing processes


* Active participation in internal, customer, and health authority inspections as lead Subject Matter Expert


* Maintain excellent and collaborative relationships with all business p...