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.
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. You have demonstrated experience creating and executing VMP, IQ, OQ, and PQ activities, and you hold a bachelor’s degree in Engineering, Life Sciences, or a related technical discipline such as Mechanical, Chemical, Biomedical, or Industrial Engineering. To succeed in this role, you need strong technical judgment, attention to detail, and the ability to work effectively across Quality, Engineering, Manufacturing, and other cross-functional teams. You are comfortable working in a structured, regulated environment and can balance compliance, quality, and business needs while supporting consistent validation practices across sites. Just as importantly, you value collaboration and understand 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)
Why Alleima, BU Medical?
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. Are you ready to take on this challenge together with us? Join us on our journey! www.alleima.com