Senior Quality Engineer - Fixed Term Contract

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

Title: Senior Quality Engineer - Fixed Term Contract

Requisition ID: 75768

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.

Job Summary

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.

Essential Duties and Responsibilities

• 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

Education

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

Work Experience

• 5+ years of relevant work experience required.

Preferred Knowledge, Skills and Abilities

• 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 the position covered by this Job Description.
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target.
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.

License and Certifications

• Manufacturing\\Six Sigma Green Belt Certification or Black Belt upon hire, preferred.
• Quality\\Certified Quality Technician-ASQ (CQE or CQA) upon hire, preferred.
• ISO 17025 Auditor or Lead Auditor Training / Certification upon hire, preferred.

Travel Requirements

10%: Up to 26 business days per year

Physical Requirements

Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

Additional Requirements

• Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• Excellent written and oral communication and interpersonal abilities, with the capacity to communicate complex technical concepts to diverse stakeholders.
• Ability to work independently, multi-task and thrive in fast-paced environment.
• Strong problem-solving skills including root cause failure analysis methods.
• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
• Must maintain the ability to work well with others in a variety of situations.
• Critical reading skills and maintain high attention to detail, accuracy, and overall quality of work.
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Ability to make independent and sound judgments.
• Observe and interpret situations, analyze and solve problems.

What We Offer

Community Involvement: West encourages volunteerism through its West without Borders initiative and other charitable programs that make a difference in local communities. Continuous Learning & Development: Opportunities for professional growth through training programs, tuition assistance, leadership development, and skill-certification initiatives. Generous Paid Time Off (PTO): Flexible vacation, personal, and holiday leave ensures employees can maintain a healthy work-life balance and recharge effectively. Global Career Opportunities: With facilities across North America, Europe, and Asia-Pacific, employees have opportunities for international exposure and cross-functional collaboration. Inclusive & Collaborative Culture: A global workforce that values diversity, equity, and inclusion—where all voices are heard and respected in a supportive environment. Recognition & Rewards: Performance-based bonuses, service recognition, and employee appreciation initiatives celebrate dedication and impact. No relocation is provided for this opportunity. This is an onsite position requiring the team member to be onsite 5 days per week. West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening.