Validation Engineer

Location

Palm Coast, United States of America.

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.

• 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.
• Values collaboration and understands that every role matters in building reliable processes that support better healthcare.

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.

Competitive compensation, benefits, and global career development.

• Heath, 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).