Senior Validation Engineer

2 weeks ago

Tucson, United States Roche Full time
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.

As a Senior Validation Engineer, you ensure that validation and procedure requirements are met for all equipment, facilities, utilities, systems and processes by preparing, reviewing, approving and executing detailed qualification and validation protocols. You ensure these meet relevant testing standards in support of the site. You partner with the Maintenance, New Product Transfer, and Operations teams to ensure the manufacturing process is robust and has the capability and capacity to meet the needs of our patients and customers.

The Opportunity
  • You continuously improve and expand capabilities in validation strategies, planning, review and documentation and advise teams on the selection and deployment of appropriate tools and standards.
  • You provide guidance in engineering, design and process best practices and/or scale-up relative to validation activity. You share your deep technical knowledge of qualification of equipment, facilities, utilities, and process validation with the team.
  • You apply Project Management tools to define and monitor project timelines, ensuring timely achievement of overall project goals and establishing priorities that are in line with the overall business needs.
  • You write and execute Equipment, Facility, and Utilities Installation/Operational/Performance Qualifications (IQ/OQ/PQ) protocols and Process Validation protocols.
  • You collaborate with other functions in MTS (Manufacturing Technical Support) such as Process Engineering, Maintenance and Design Transfer teams to ensure alignment of MTS projects are communicated effectively and implemented in a structured and thorough way. This includes partnering with operations to ensure compliance to cGMP, FDA and ISO13485 guidelines.

Who You Are
  • You have a Bachelor's Degree in Engineering/Engineering Technology or Life Science. An equivalent combination of education and/or experience is accepted.
  • You have 4-10 years of related experience in a manufacturing environment.
  • You have at least 1 year of experience in a regulated industry (preferably FDA with knowledge of Design Control Guidelines).

Preferred
  • You can apply Lean and 6 Sigma methodology in all that you do and have a passion to drive it throughout the organization.
  • You are proficient in Minitab statistical software and SAP.
  • You have experience with equipment/facility validation within a Medical Device, Diagnostics, Biotech or Pharmaceutical organization.
  • You are ISPE Certified.

Locations

This is an on-site opportunity in Tucson, Arizona.

Relocation benefits are not available for this position.

The expected salary range for this position based on the primary location Tucson, Arizona is $71,600 to $133,000. 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

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. Our integrated staining, workflow management and digital pathology solutions optimize laboratory efficiency to reduce errors and support diagnosis for pathology professionals. Together with Roche, Ventana is driving personalized healthcare through accelerated drug discovery and companion diagnostics.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

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