Senior Qualification & Validation Engineer

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

Doing now what patients need next. A pioneer in the development of blood glucose monitoring and insulin delivery systems, Roche Diagnostics - Near Patient Care is committed to helping people with diabetes everywhere in the world think less about their daily diabetes routine, so they can get true relief, day and night. We offer a broad portfolio of solutions for both people with diabetes and their professionals - from blood glucose monitoring to information management to insulin delivery to continuous glucose monitoring. Our aim is to offer innovative products, services and comprehensive solutions for convenient, efficient and effective diabetes management.

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.

The Opportunity

• 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

Validation management, definition of validation relevance and validation strategy, creation of test specifications and trace matrices if necessary:

• 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

Review of requirements, functional specifications, risk analyses, development tests and software deployment:

• Content review and representation of compliance aspects

• Coordination with the affected interfaces regarding the scope of software verification (e.g. unit/module tests)

Who You Are

• 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.

Skills

• 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

Relocation benefits are not available for this posting

The expected salary range for this position based on the primary location of Indianapolis, IN is $83,600 - $155,200. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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