Senior Validation Engineer

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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 the Senior  Validation Engineer, you will support validation activities as a member of the Validations Team. Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols with input/oversight from manager & senior validation engineers. These activities are related to re-validations, new projects, and new product introductions.

Ensures that the requirements facilitate robust validation activities that will conform to the user needs and intended purpose. Identifies and assists with implementing improvements around current validation processes with guidance from manager and senior validation engineers. Assist in the troubleshooting of issues to determine root cause and possible engineering solutions.

The Opportunity

• Prepare and execute IQ, OQ, and PQ for equipment, systems, and processes. Apply cGMP and cGDP to all areas of work.

• Apply Program 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.

• Analyzes data, evaluates results, forms conclusions and provides/implements process or document improvements.

• Ensures collaboration with the Process Engineering and IMT teams to ensure that new manufacturing processes are designed and implemented in a manner such that the performance of the system can be fully validated.

• Shares knowledge and expertise with others. Makes suggestions to improve work processes.

• Partners with Technical Transfer and Development team members to ensure validation requirements are addressed.

• Other duties as assigned by management.

Who You Are

• You hold a Bachelor's degree in Engineering/Engineering Technology or Life Science discipline

• You have 1-4 years of related experience.

Preferred Requirements

• Experience in a Regulated Industry preferably GDA and knowledge of Design Control Guidelines.

Behaviors, competencies, and qualities of the ideal Senior Validation Engineer

• Demonstrates potential for technical proficiency, engineering creativity, collaboration with others and independent thought.

• Understanding in the manufacture of assays, reagents and instruments as well as Verification and Validation principles, practices and tools used in that transfer.

• Proven ability to work on complex problems with analysis of situations or data towards successful outcomes.

• Must have the ability to manage priorities based on the needs of the manufacturing area with some guidance from the reporting manager and senior management.

• Proven ability to contribute and interact productively and collaboratively with project team.

• Strong communication and technical writing skills for protocol and report generation.

The expected salary range for this position based on the primary location of Tucson, AZ is 65,000.00 - 120,800.00 USD Annual. 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

Are you ready to apply?

Relocation benefits are available for this position.

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 diver