Senior Engineer, R&D, Lab

This is an onsite position requiring the team member to be onsite 5 days a week.

Who We Are – At West, we’re a dedicated team connected by a purpose to improve patient lives, a purpose 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 U.S. Government during World War II. Through our work delivering 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. We offer an inclusive community of professionals with opportunities for lifelong learning, growth, and development, supported by benefit programs that empower the physical, mental, emotional, and financial health of our team members and their families.

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.

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.
• Ensures laboratory procedures are compliant with the global Quality Management System, OSHA, and 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 inwardly with lab staff to assign appropriate resources.
• Plans, schedules, and leads Lab Technicians through execution of laboratory tests.
• Participates in the development of project scope and timeline in project core team meetings.
• Assists in designing, troubleshooting, and testing laboratory fixtures 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, implementing 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, instructions, and safety rules.

Preferred 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 and keen analytical abilities.
• Excellent communication and interpersonal relations skills.
• Excellent technical writing skills with experience authoring SOPs, work instructions, protocols, and reports.
• Proficiency in the 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 (desired).

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. Experience with GMP, medical devices, and needle‑based injection systems is preferred.

Travel Requirements

10 % travel: up to 26 business days per year.

Physical Requirements

Medium‑exerting: up to 50 lb (22 kg) of force occasionally and/or up to 20 lb (9 kg) frequently, and/or up to 10 lb (4 kg) constantly to move objects.

West is an equal opportunity employer and values diversity. 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. If you need a special accommodation to apply, please email Apply.Accommodation@westpharma.com.