Senior Quality Engineer - Fixed Term Contract

RiseMe; Tempe (AZ); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

PTO

Tuition assistance

Leadership development

Global career opportunities

Volunteer opportunities

Job summary

West Pharmaceutical Services in Tempe, AZ, is seeking a dedicated validation professional for an onsite 9-month fixed-term contract. The role focuses on supporting plant validation activities and ensuring compliance with regulatory and ISO management standards.

The ideal candidate will plan, execute, and document validation life cycle activities, provide guidance to stakeholders, and maintain up-to-date industry practices and change control processes.

Qualifications

• Bachelor's Degree in Engineering or Science is required.
• 5+ years of relevant work experience in validation.
• Knowledge of FDA, cGMP, ISO and Clean Room standards.

Responsibilities

• Provide support for the validation program and ensure regulatory compliance.
• Document validation requirements to guide customers and regulatory bodies.
• Guide stakeholders on content and format of validation life cycle documentation.
• Lead and execute software validation activities.
• Support Engineering and Operations during process development and validation phases.
• Provide training for qualification activities.
• Review and approve validation documentation (PDD, IOQ/PQ, summaries).
• Ensure changes are properly controlled and tracked.

Skills

Validation

Software validation

Regulatory compliance

Documentation

Communication

Education

Bachelor's Degree in Engineering or Science

Tools

Validation software

PDD/IOQ/PQ protocols

Job 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 involved 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 opportunityThis 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.