Senior Associate II, Quality Engineering (m/w/d)

Beschreibung

• Responsible for supporting the setup and structure of the automation and MES systems (Delta V and Syncade)to enable the start-up, commissioning and validation of the new Large Scale Manufacturing facility
• Review and approve GMP documentation (Plans, protocols, procedures, CAPAs, deviations, etc.) specifically related to automation and MES systems (Delta V, Syncade, etc.)
• Provide support to multiple areas within the facility; requiring a good working knowledge of regulatory and Company´s Quality and Process systems as well as working knowledge of key automation/MES systems
• 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.)
• Performs Quality review and approval of change control documents and activities associated with change control

• Bachelor's Degree in relevant field such as Chemical Engineering, Mechanical Engineering, Bio-Engineering, Automation Systems, Computer Science
• Approximately 8 - 10 years of experience in pharmaceutical or biotech manufacturing environment. Previous experience within Quality Assurance, Validation, Automation or related function is preferred.
• Maintain knowledge of relevant FDA/EMA regulations and compliance.
• Approximately 3 years of experience in pharmaceutical or biotech manufacturing environment.
• Previous experience within Quality Assurance or related function is preferred.
• Good communication skills in English, verbally and written.
• Technically oriented role including experience of the validation of laboratory, production equipment automation systems and knowledge of production methodology involved in biopharmaceutical production.
• Self driven, demonstrated ownership and responsibility for work assignments.
• Value teamwork at all levels and performs work with an open mind inviting input and feedback from partners across the organization. Ability to work with colleagues across the organization.