Validation Engineer

Role OverviewThis position is responsible for production validation activities, including capacity expansion, innovation, and process improvement. The incumbent will act as a Change Control Request (CCR) owner, managing the process from initiation through to mass production implementation.Duties and ResponsibilitiesConduct validation activities as assigned at HSOT, acting as the CCR owner from change initiation to mass production implementation. The scope includes capacity expansion, innovation, and process improvements.Conduct engineering tests, prepare technical documentation, and generate related reports.Assist in writing and updating procedures or work instructions to ensure efficiency, standardization, and accuracy.Conduct or support improvement and problem-solving testing.Support non-conformance product management to prevent escape or overkill judgments, collaborating with sustaining engineering, QA, QLab, and SCM to ensure accurate quality assessments prior to product release.Comply with and adhere to all Regulatory, Quality, and Environmental Health & Safety (EHS) requirements.Perform additional tasks as assigned by superiors.Requirements1–5 years of experience in a validated company, process control, or manufacturing process improvement.Experience in medical devices and knowledge of ISO 13485 standards preferred.Strong analytical and mathematical skills; proficiency with basic and field-specific software such as Minitab.Skills & Accreditations:Strong leadership, accountability, and interpersonal skills.Positive attitude with effective communication and presentation abilities.Logical thinking and strong analytical/problem-solving skills.Detail- and process-oriented, with excellent prioritization and teamwork abilities.Experience with Lean Manufacturing and a continuous improvement mindset.Ability to multi-task and organize work efficiently to meet deadlines.Familiarity with production environments and cleanroom control.Good command of written and spoken English.Academic Qualifications:Bachelor’s degree in Engineering, Science, or Health (Industrial Engineering, Systems Engineering, Chemical, Food Science, Pharmaceutical, or related fields).Travel Requirements:10–20% (as per business needs)