Validation Engineer
Job Location:
Palm Coast, FL - USA
Monthly Salary:
Posted on:
Vacancies:
Job Summary
Location
Palm Coast United States of AmericaAbout 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.
About you
You bring 37 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 bachelors 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.
What you can expect from us
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 after30 days
88 paid holiday hours per year
Paid time off (up to120 hourspaid time off after one year)
Why Alleima BU Medical
We dont just make components; we enable breakthroughs. Whether its 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!
Required Experience:
IC
About Company
Alleima is a developer and producer of advanced stainless steels, special alloys, titanium and other high-performance materials in a variety of product forms. Examples are tube, strip and wire products.
