Senior Validation Engineer

Roche • Tucson, AZ

426d

About The Position

As a Senior Validation Engineer at Roche, you will play a crucial role in supporting validation activities within the Validations Team. Your primary responsibilities will include developing and executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, ensuring that validation processes meet user needs and intended purposes. You will also collaborate with various teams to implement improvements and troubleshoot issues, contributing to the overall success of new projects and product introductions.

Requirements

• Bachelor's degree in Engineering/Engineering Technology or Life Science discipline.
• 1-4 years of related experience.

Nice To Haves

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

Responsibilities

• Support validation activities as a member of the Validations Team.
• Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Ensure that validation requirements facilitate robust activities conforming to user needs.
• Identify and assist with implementing improvements around current validation processes.
• Assist in troubleshooting issues to determine root cause and possible engineering solutions.
• Prepare and execute IQ, OQ, and PQ for equipment, systems, and processes.
• Apply cGMP and cGDP to all areas of work.
• Use Program Management tools to define and monitor project timelines.
• Analyze data, evaluate results, and implement process or document improvements.
• Collaborate with Process Engineering and IMT teams for new manufacturing processes.
• Share knowledge and expertise with others and suggest improvements to work processes.
• Partner with Technical Transfer and Development team members to address validation requirements.

Benefits

• Discretionary annual bonus based on individual and Company performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 10,001+ employees