The Senior Validation Engineer will be responsible for validation oversight of External Manufacturing sites (API, DS/DP), including process, cleaning, filter and sterilization/sanitization validation activities.
• Be an integral quality member cross-functional contract manufacturing teams that includes but is not limited to business operations, analytical science, process development, supply chain XPD etc.
• The Senior Validation Engineer will translate requirements into the language of the CMO-can make a risk-based decision
• Validation document author/approver
• Ensure validated parameters are correctly incorporated in Master Batch Records
• Regulatory - Aseptic processing system oversight (media fill, autoclave validation, EM) content authorship
• Validation change control assessment
• Perform Person in Plant activities as required
• The Senior Validation Engineer will prepare inspection playbooks, Write/review RTQs and Author applicable MA filing sections
• Determine validation strategy and outcome of validation activities
• Degree qualified in science and/or engineering
• 5 + years biotech or pharmaceutical industry experience
• Significant Validation experience at Aseptic Manufacturing or API facilities
• Able to facilitate and influence senior stakeholders and partners
• Familiarity with basic project management tools
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