Principal 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.

We are strongly committed to a diverse and inclusive workplace. We strive to build teams that represent a range of backgrounds, perspectives, and skills. Embracing diversity enables us to create a great place to work and to innovate for patients.

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 Principal 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 the most 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 possess strong leadership skills, and drive cross-functional coordination and collaboration to achieve validation goals at your site. You act as a coach and consultant for your peers on site by using your broad subject matter expertise. You help to encourage and develop other team members.

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

• Accomplish the most complex tasks on a program, platform, and project level team, across ARTs and networks, or as an individual contributor.

• Propose, develop, and execute or lead validation plans and activities to ensure compliance and high quality within complex projects and environments.

• Coordinate, participate and report in evaluation and decision boards to ensure validation readiness and analyze the validation relevance.

• Act as the site point of contact in internal and external audits.

• Act as the site point of contact for validation and qualification topics related to external partners.

• Maintain the validation program, including co-definition and monitoring of KPIs.

• Develop and maintain local validation deliverables and tools.

• Act as a local process manager for Process Validation: align with the global process owner on business needs, regulatory expectations, and process optimization techniques needed to establish and maintain compliant and efficient QMS procedures well understood by users.

• Act as a coach / consultant with broad subject matter expertise.

Be an active peer coach and mentor to members of the chapter on site to help them grow as Validation

Professionals

• Act as a mentor and coach for colleagues in your area of expertise. Coach, encourage, and develop individuals within the organization.

• Assist peers in navigating complex and challenging topics in Process Validation to raise the level of performance of the organization, encourage knowledge sharing, and proactively solve difficult problems.

• Foster cross-functional collaboration and breaking down silos to achieve the best results for the organization

• Navigate and influence within a changing organization, maintaining objectivity, respect for differences of opinion, fairness, open communication and consensus building skill

Enable the organization's New Ways of Working and support access to the right resources

• Act as role model for Agile Leadership behaviors, as well as for our culture, mindset & behaviors as defined in the Roche Operating Principles

• Work closely with ARTs, similar functions across Roche, and leaders across the business to identify and translate strategic direction into capability needs

Who You Are

• Bachelor's Degree in engineering, physical science or a related field.

• 8+ years of experience in a highly regulated industry, preferably within the medical device/ diagnostics field

• Broad knowledge of the manufacturing processes and data integrity. Significant experience in validation of equipment, non-product software, clean rooms, and cleaning procedures.

• Profound knowledge of validation relevant regulations, standards and associated guidelines pertinent to the industry (e.g. ISO 13485, US 21CFR 820, IVDR / MDR, etc.)

• Experience in statistical process control techniques, significant experience in leading projects

• Strong knowledge of continuous process improvement and/or lean / agile processes

• Demonstrated ability to communicate, collaborate, and influence effectively with a variety of internal and external stakeholders in demanding / changing situations to build trust, confidence, and collaboration toward shared objectives

• Project management experience with proven leadership, mentoring, and coaching abilities

• Strong interpersonal, analytical, and problem-solving skills

• German language skills are preferred to facilitate collaboration with counterparts in Mannheim and other German-speaking sites.

Relocation benefits are available for this posting

The expected salary range for this position based on the primary location of Indianapolis, IN is $105,000 - $196,000. 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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