Senior Quality Engineer - Validation Lead (Onsite, 9-Month)

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

Benefits offered by this job

Paid Time Off

Tuition Assistance

Training & Development

Global Career Opportunities

Inclusive & Collaborative Culture

No Relocation

Job summary

West Pharmaceutical Services, Inc in Tempe, AZ is seeking a Senior Quality Engineer for a 9-month fixed-term contract. The onsite role requires 5 days per week on site with no relocation assistance.

The candidate will support the validation program, ensuring compliance with regulatory and ISO standards, and will lead documentation and protocol activities. Requirements include a Bachelor's degree in engineering or science and 5+ years of relevant experience.

Qualifications

• Bachelor's degree in engineering or science or equivalent experience.
• 5+ years of relevant work experience in quality/validation.
• Experience writing, executing and summarizing protocols preferred.

Responsibilities

• Ensure compliance to West’s validation program.
• Document validation requirements to meet customer and regulatory needs.
• Provide guidance on validation lifecycle documentation.
• Plan, establish and execute software validation activities.
• Support process development and validation phases for products.
• Train staff for qualification activities.
• Review/approve validation documentation (PDD, IOQ/PQ, reports).
• Guide protocol incidents and resolve deviations.
• Keep current with FDA, ISO standards for validation and change control.

Skills

Validation experience

Regulatory compliance

Quality systems

Documentation

Risk management

Lean Sigma

FDA/cGMP ISO knowledge

Communication

Education

Bachelor's Degree in Engineering or Science

Tools

Change control

Job description

West Pharmaceutical Services, Inc in Tempe, AZ is seeking a Senior Quality Engineer for a 9-month fixed-term contract. The onsite role requires 5 days per week on site with no relocation assistance.

The candidate will support the validation program, ensuring compliance with regulatory and ISO standards, and will lead documentation and protocol activities. Requirements include a Bachelor's degree in engineering or science and 5+ years of relevant experience.