Senior Quality Validation Engineer (Onsite)

West Pharmaceutical Services, Inc; Tempe (AZ); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Paid Time Off

Tuition Assistance

Global Opportunities

Volunteer Programs

Inclusive Culture

Recognition & Rewards

Job summary

West Pharmaceutical Services, Inc in Tempe, AZ is seeking an experienced Validation Engineer to support the plant's validation program, ensuring compliance with FDA, ISO, and cGMP standards. This is a 9-month fixed-term contract with on-site work five days per week.

Responsibilities include documenting validation life cycles, guiding stakeholders, reviewing protocols, and supporting process development and risk management.

Qualifications

• Bachelor's degree in engineering or science required (or equivalent).
• 5+ years of relevant work experience.
• Experience writing, executing and summarizing protocols.
• Knowledge of FDA, cGMP, ISO standards.
• Lean Sigma or quality program experience preferred.

Responsibilities

• Provide support for the plant's validation program and ensure regulatory compliance.
• Document validation life cycle requirements to guide customer and internal stakeholders.
• Review and approve validation documentation (PDD, IOQ/PQ, protocol addenda, reports).
• Coordinate risk management and change-control activities per ISO 14971 and ISO 31000.
• Assist with process development and training related to qualification activities.

Skills

Validation planning

Regulatory compliance

Documentation

Cross-functional collaboration

Problem-solving

Education

Bachelor's degree in Engineering or Science

Tools

Software validation

Job description

West Pharmaceutical Services, Inc in Tempe, AZ is seeking an experienced Validation Engineer to support the plant's validation program, ensuring compliance with FDA, ISO, and cGMP standards. This is a 9-month fixed-term contract with on-site work five days per week.

Responsibilities include documenting validation life cycles, guiding stakeholders, reviewing protocols, and supporting process development and risk management.