Senior Lab Engineer - Design Verification Testing

West Pharmaceutical Services / Progressive Medical; Scottsdale (AZ); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

PTO

Professional development

Volunteer programs

Inclusive culture

Onsite work

Job summary

West Pharmaceutical Services in Scottsdale, AZ seeks a Senior Lab Engineer to support test equipment qualifications, fixture/jig design, and test method development. You will lead validations under the Lab Manager and mentor junior engineers in a fast-paced, GMP-regulated environment.

Onsite five days a week with opportunities to contribute to process improvements, author SOPs, and collaborate with project teams to ensure timely, compliant testing of needle-based injection systems and related

Qualifications

• Minimum 5 years in a regulated engineering environment.
• Experience with GMP and medical devices preferred.
• Needle-based injection systems experience is a plus.

Responsibilities

• Lead test method development and validation planning.
• Coordinate testing with project managers and verification engineers.
• Draft fixtures/jigs designs and CAD models.
• Ensure lab procedures comply with QMS and regulations.
• Travel up to 10% for external testing.

Skills

GMP experience

Mentorship

Leadership

Statistical analysis

Minitab

Analytical skills

Communication

Problem-solving

Education

Bachelor's degree in engineering

Tools

SolidWorks CAD

Instron

Zwick machines

MS Office

Job description

Description

This is an onsite position requiring the team member to be onsite 5 days a week. No relocation is provided for this opportunity

Who We Are

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

In this role, the Senior Lab Engineer will work under the direction of the Lab Manager to assist with test equipment qualifications, test fixture/jig design, test method development, and test method validations. This individual will bring excellent analytical and engineering skills, as well as leadership and mentoring talent to the execution of development projects at West.

Essential Duties And Responsibilities

• Provides subject matter expertise, leadership, and mentoring in the development of test methods, as well as the planning and coordination of test method validations for needle-based injection systems.
  • Ensure Laboratory procedures are compliant with global Quality Management System, OSHA, local, state and federal environmental regulations.
  • Creates test programs on tensile/compression testing machines.
  • Ensures lab equipment and environmental chambers receive the appropriate level of qualification for their intended use.
  • Authors and executes test method procedures, test method validation protocols/reports, and equipment qualification protocols/reports
• Works outwardly with Project Managers and Verification Engineers to plan and coordinate testing needs, and then inwardly with lab staff to assign appropriate resources.
  • Planning, scheduling, and leading Lab Technicians through execution of laboratory tests.
  • Participates in the development of project scope and timeline in project core team meetings.
• Assists in the designing, troubleshooting, and testing of laboratory figures and jigs as part of test method development activities.
  • Drafts engineering drawings of fixtures and jigs for manufacturing.
  • Manages CAD models and drawing revisions.
• Occasional travel to support design verification testing with external laboratories.
• Recognizes inefficiencies and takes initiative to improve processes and implement procedures to streamline workflows and increase effectiveness. Authors new and revises existing lab SOPs.

Additional Responsibilities

• Maintains a clean and tidy laboratory environment that is audit-ready at all times.
• Demonstrates a “Customer Service” attitude when interacting with internal and external customers
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.

Education

• Bachelor’s degree in engineering or equivalent experience required (mechanical engineering or biomedical engineering preferred)

Work Experience

• Minimum 5 years of experience in a regulated engineering environment.
• Work experience with GMP, medical devices, and needle-based injection systems preferred.

Preferred Knowledge, Skills And Abilities

• Proficiency in statistical data analysis using software packages such as Minitab.
• Strong leadership qualities and mentorship to junior level engineers.
• Excellent problem-solving skills as well as keen analytical abilities.
• Excellent communication and interpersonal relations skills.
• Excellent technical writing skills with experience authoring SOPs, work instructions, protocols, and reports.
• Proficiency in MS Office suite including PowerPoint, Word, Excel and Outlook.
• Experience using and programming Instron and Zwick machines a plus.
• Proficiency in CAD design and drafting in SolidWorks a plus
• Knowledge of specific ISO standards - Quality Management Systems for Medical Devices and needle-based injection systems a plus.
• Works well in a fast-paced environment, with minimal supervision and guidance.
• Track record of proven mechanical ability and troubleshooting skills is desired.

Travel Requirements

10%: Up to 26 business days per year

Physical Requirements

Medium-Exerting up to 50lb/22kg of force occasionally and/or up to 20lbs/9kg of force frequently, and/or up to 10lbs/4kgs of force constantly to move objects.

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.
• Inclusive & Collaborative Culture: A global workforce that values diversity, equity, and inclusion—where all voices are heard and respected in a supportive environment.
• This is an onsite position requiring the team member to be onsite 5 days a week.

West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening.