Senior Engineer I, Validation

Job Overview BeOne continues to grow rapidly, offering a Site‑Based Validation Manager position focused on scientific and business excellence in cancer therapeutics. The role engages in day‑to‑day Validation activities, manages large projects, and upholds cGMP and regulatory compliance while meeting commercial objectives. Responsibilities Engage in day‑to‑day activities of the Validation function, ensuring successful management of related activities and large projects. Support Validation objectives while adhering to regulatory compliance and achieving commercial success. Ensure operational compliance and support KPIs such as SOP‑mandated cycle times and on‑time closure dates. Create and review SOPs needed to support the business. Support both internal GMP audits and Health Authority audits. Assist with Validation related tasks as assigned by Management. Develop and approve cGMP documents—including equipment and instrument qualification, commissioning, Master Validation Plans, SOPs, comparability reports, aseptic process simulation protocols, PPQ process validation, cleaning/sterilization validation. Lead validation activities for projects, review documentation, and attend validation activities (FAT, SAT, IQ, OQ, PQ). Ensure the Validation department meets or improves KPIs. Ensure all validation projects are on time and on budget. Ensure adequate validation resources. Manage validation consultants on a large project basis, as needed. Lead and manage projects for validation of equipment, processes, and products to meet safety, quality, regulatory, and operational requirements. Review equipment specifications, design, procurement, installation, and validation. Plan and execute projects, including scheduling, task management, milestone planning, and reporting. Generate, review, and approve project documentation (User Requirement Specifications, validation protocols, reports) and Standard Operating Procedures. Collaborate closely with manufacturing, quality, and engineering associates. Maintain validation sample management, assess data acquisition requirements, and coordinate validation projects. Investigate validation discrepancies, errors, protocol failures, and testing errors, and document review and action to reconcile deviations. Position flows based on project needs up to and including quality approvals. Undertake any other duties for any department within the business as requested by the Line Manager, after training and explanation. Qualifications & Experience BS or higher in engineering or related discipline OR a minimum of 9 years relevant experience. Minimum 5 years of experience in biopharmaceutical manufacturing, engineering, and/or Validation. Scientific degree (pharmaceutical sciences, engineering, chemistry, or related discipline). Strong knowledge of cGMP and Data Integrity principles. Knowledgeable in risk assessments and risk‑based approaches. Biotech and/or sterile manufacturing and aseptic processing knowledge required. Minimum of 5 years’ experience in validation (with a Bachelor’s) or 4 years (with a Master’s). Demonstrable track record and skills gained within a similar position at a similar level. Good personal leadership, strong communication (written and verbal) at all levels, customer‑focused, strong analytical and problem‑solving skills. Hands‑on approach, ‘can‑do’ attitude, ability to work under minimal supervision, prioritize tasks, and demonstrate excellent time management. Attention to detail, ability to work accurately in a busy and demanding environment, self‑motivated, proactive initiative, and initiative. Technical Skills Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Project). Knowledge of SAP desirable but not required. Knowledgeable in Computerized System Validation (CSV) and/or Automation Validation. Experience with project management tools such as Microsoft Project, AutoCAD, Smartsheet. Familiarity with data management and visualization tools (e.g., SharePoint, Teams, Power BI, Veeva Vault, eQMS or similar). Ability to create and maintain Gantt charts, dashboards, and tracking templates. Physical & Travel Requirements Ability to work in an office environment, construction site, laboratory, or manufacturing areas. May require up to 5% travel, including visits to partner or manufacturing sites. Must be able to sit, stand, and use standard office equipment for extended periods. Salary and Benefits Salary Range: $109,900.00 – $149,900.00 annually. Benefits include Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness programs. Equal Employment Opportunity BeOne is a proud equal‑opportunity employer. We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other protected class. All employment is decided on the basis of qualifications, merit, and business need. #J-18808-Ljbffr BeiGene, Ltd.