Senior Quality Engineer - Onsite 9-Month Contract

West Pharmaceutical Services, Inc; Tempe (AZ); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Onsite 5 days a week

Job summary

West Pharmaceutical Services, Inc in Tempe, AZ is seeking a Senior Quality Engineer for a 9-month fixed-term contract. This onsite role requires the incumbent to be onsite 5 days a week, with no relocation provided.

The position supports the validation program and ensures compliance to regulatory and ISO standards. The candidate will lead validation activities, document life-cycle packages, and coordinate with engineering and operations to advance product life cycles.

Qualifications

• Bachelor's Degree in Engineering or Science (or equivalent experience).
• 5+ years of relevant work experience.
• 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.

Responsibilities

• Ensure compliance to West's validation program.
• Document validation requirements for customers and regulatory bodies and West groups.
• Guide stakeholders on the content and format of Validation life cycle documentation.
• Plan, establish and execute software validation activities.
• Support Engineering and Operations during process development and Validation phases.
• Provide training to support qualification activities.
• Review and approve validation life cycle documentation (PDD, IOQ/PQ, etc.).
• Guide protocol incidents process (reporting, investigations, resolutions).
• Keep current with Industry standard practices and FDA requirements for validation, change control and complaint handling.
• Monitor Change Control system and ensure timely closure of requested actions.
• Understand and apply ISO 14971 and ISO 31000 risk documentation.

Skills

Quality

Software validation

Regulatory compliance

Documentation

Risk management

Change control

Lean Sigma

Communication

Team collaboration

FDA knowledge

Education

Bachelor's Degree in Engineering or Science

Job description

West Pharmaceutical Services, Inc in Tempe, AZ is seeking a Senior Quality Engineer for a 9-month fixed-term contract. This onsite role requires the incumbent to be onsite 5 days a week, with no relocation provided.

The position supports the validation program and ensures compliance to regulatory and ISO standards. The candidate will lead validation activities, document life-cycle packages, and coordinate with engineering and operations to advance product life cycles.