About the position
At Roche, we are passionate about transforming patients' lives and we are fearless in both decision and action - we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. Internal Manufacturing Indianapolis is a function within Roche Diagnostics - Near Patient Care Operations, responsible for the strip manufacturing of the majority of our blood glucose monitoring portfolio for the global demand of our patients. As a Senior Qualification & Validation Engineer, you hold the highest level of subject matter expertise within Qualification & Validation of systems and processes. You are capable of identifying and addressing complex and challenging topics within your area of expertise, either as an individual or as a member of a cross functional team in an Agile Release Train (ART) or a manufacturing value stream. You will partner with all levels of the organization, including individual contributors within Engineering & Lifecycle Quality (ELCQ), chapter and sub-chapter leaders, colleagues across the enterprise, and senior leadership, as needed.
Responsibilities
- Management of process and software validation projects in various areas, e.g. Operations, R D and Quality: definition of validation relevance and validation strategy
- Creation of validation-relevant documents, e.g. validation (master) plans and reports, test specifications and traceability matrices where applicable
- Technical representation of validation in the creation of system documents, development tests, risk analyses, changes and CAPAs
- Participation in internal and external audits
- Management of the inventory database for validated systems
- Ensuring that all prescribed prerequisites/deliverables for start validation are fulfilled
- Coordinating the necessary validation phases and test content with representatives of the affected interfaces, e.g. IT, automation, mechanics, quality, etc.
- Participation in project meetings and maintenance of status reports
- Estimating the workload for capacity planning
- Sharing project results and experiences with the validation team
- Participation in audits & CAPAs, maintenance of the inventory database and optimization of the validation process
- Coordinating the required deliverables with the affected interfaces
- Active exchange of project experience and regulatory knowledge with the validation team to optimize the validation process
- Support in maintaining the key performance indicators
- Content review and representation of compliance aspects
- Coordination with the affected interfaces regarding the scope of software verification (e.g. unit/module tests)
Requirements
- Bachelor's degree
- At least 5 years of professional experience with process and software validation in a GMP-regulated environment, preferably with CSV projects in the field of medical devices
- Project management and agile techniques
- Risk management
- ISO-13485, 21 CFR Part 11 and GAMP 5
- Working with Electronic Documentation Management Systems
- Good MS Office skills
Benefits
- Discretionary annual bonus based on individual and Company performance
