Validation Engineer

About the role

In this mid-level role, you will plan, execute, and document validation activities that support compliant operations across the product and process lifecycle while partnering with cross-functional teams throughout BU Medical.

• Lead and execute equipment, process, and system qualification and validation activities, including VMP, IQ, OQ, and PQ, in line with internal procedures and applicable regulatory requirements.
• Develop, review, and approve validation master plans, protocols, reports, and supporting documentation.
• Partner with Manufacturing, Engineering, Quality, Regulatory, and Supply Chain to support new product introductions, capacity expansions, equipment transfers, and site expansion activities.
• Ensure validation practices meet customer requirements, internal standards, and regulatory expectations, including FDA and ISO requirements.
• Maintain validation lifecycle compliance through change control, revalidation, periodic review, and support for deviations, CAPAs, and nonconformances.
• Participate in internal audits, customer audits, and regulatory inspections, including preparation of validation evidence and responses.
• Provide technical guidance to site teams and contribute to continuous improvement through standardization, templates, best practices, and risk mitigation.
• Ability and willingness to travel internationally up to 50% of the time as required by business needs.

Requirements

You bring 3–7 years of experience in equipment, process, or system validation within a regulated manufacturing environment such as medical device, pharmaceutical, biotechnology, or a comparable industry.

• Demonstrated experience creating and executing VMP, IQ, OQ, and PQ activities.
• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline such as Mechanical, Chemical, Biomedical, or Industrial Engineering.
• Strong technical judgment, attention to detail, and the ability to work effectively across Quality, Engineering, Manufacturing, and other cross-functional teams.
• Comfortable working in a structured, regulated environment and can balance compliance, quality, and business needs while supporting consistent validation practices across sites.
• Value collaboration and understand that every role matters in building reliable processes that support better healthcare.

Benefits

• Health, Dental, and Vision coverage after 30 days.
• 401K with company contribution of 5% plus matching after 30 days.
• 88 paid holiday hours per year.
• Paid time off (up to 120 hours paid time off after one year).
• Competitive compensation and global career development opportunities.

About Us

We don't just make components; we enable breakthroughs. Whether it's helping someone with diabetes live more freely or supporting the next generation of neurostimulation devices, our work is purpose-driven and technically sophisticated.

A workplace built on care, for better healthcare, for our customers, and for each other. A culture that values unique, novel solutions and high-quality standards. Opportunities to contribute to medical innovations that make a real difference. A collaborative, decentralized environment where your voice matters.