Senior Quality Engineer

Requisition

Date:
Sep 23, 2026

Location:

Tempe, AZ, US, 85288

Department:
Quality

Description:

This is an onsite position requiring the team member to be onsite 5 days a week. No relocation is provided for this opportunity.

This is a 9-month Fixed Term Contract.

At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun.

A name started our story. How will yours help write our future?

There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Provide support for the validation program for the plant or assigned functional area regarding equipment, processes or procedures used. Ensure compliance to regulatory and ISO Management standards.

• Responsible for compliance to West's validation program.
• Ensure that the validation requirements are documented to provide direction for meeting the validation needs of the customers, associated regulatory bodies and West functional groups.
• Provide guidance to system/process stakeholders as to content and format of Validation life cycle documentation.
• candidate shall demonstrate hands-on experience planning, establishing and executing software validation activities.
• Support Engineering and Operations groups during the process development and Validation phases of customer products’ life cycles.
• Provide required training to support qualification activities.
• Assume the QA responsibilities for reviewing and approval of validation life cycle documentation (PDD, IOQ/PQ protocols, protocol addendums, summary reports, etc.)
• Provide guidance during protocol incidents process, including reporting, investigations and approval of resolutions.
• Keep current with all Industry standard practices and FDA requirements for validation, change control and complaint handling.
• Monitor Change Control system and provide guidance for proper execution and timely closure of Change Controls and Action items.
• Understanding and facilitation of Risk documentation to ensure compliance with ISO 14971 and ISO 31000.
• Ensure compliance with Quality, Business Continuity, Safety and Environmental standards and applicable regulations.
• Experience with risk management and task prioritization a must for this role.
• Other duties as assigned. #LI-AP1 #LI-ONSITE

• Bachelor's Degree in Engineering or Science, or equivalent experience required.

• 5+ years of relevant work experience required.

• 2+ years of experience writing, executing and summarizing protocols.
• Knowledge of FDA, cGMP, ISO and Clean Room standards.
• Knowledge of validation of automated assembly, software, and manufacturing processes.
• Knowledge of ANSI/ISO standards.
• Excellent written and verbal communication skills.
• Good problem-solving skills and be able to function independently or as a member of a team.
• Able to be aware of all relevant SOPs as per Company policy as they are related to…