1. You provide support to manufacturing areas within the facility for upcoming deviations and CAPAs related to equipment and automation of the production process and applying regulatory and compliance knowledge from multiple markets / agencies.
2. You review and approve complex GMP documentation (Changes, plans, protocols, technical documentation, etc.) related to modifications of existing equipment and automation and may participate on projects requiring a high knowledge level of regulatory and Biogen Quality and Process systems .
3. In addition, you support ongoing production and maintenance processes reviewing and approving related work orders in the electronic maintenance management system (EMMS).
4. You work with the senior Quality Engineering Team to identify / revise / develop and implement complex Quality systems that can be global in scope.
5. You ensure adherence to internal procedures for facility / equipment controls and release before, during and after production operations (i.
e. routine operations, shutdowns, construction projects, product changeover, etc.)
6. You interact with regulatory agencies directly during audits as well as providing input into such documents as regulatory filings (may be expected to act as primary author for sections of filings)
The Senior Quality Engineer will support the ongoing production and maintenance of the new Large Scale Manufacturing facility located in Luterbach, Switzerland.
It is a technically orientated role requiring experience of the validation of production equipment and knowledge of production methodology involved in bio-pharmaceutical drug substance production .
In this role the Senior Quality Engineer is responsible for Quality oversight to review and approve validation and engineering life cycle documents (User Requirement Specifications, Risk Assessments, Race Matrixes, Design Documents and drawings etc.
test protocols, CAPAs, deviations, change controls, work orders and any technical documentation in the scope of Facilities, utilities, equipment and Biogen Execution System (global and local computerized systems).
The Senior Quality Engineer reports to the Head of Quality Biogen Execution and needs to co-operate with multiple functions, including engineering, automation, validation, Manufacturing personnel, SME’s on equipment and knowledge of biotechnology API production.