Validation Engineer

Responsibilities

The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment qualification.

The project is being driven by audit findings and identified gaps in the site's validation program. The primary focus will be equipment validation, especially around tanks used for drug substance mixing and drug product filling.

• Audit findings and identified gaps in the site's validation program
• Support equipment validation, especially around tanks used for drug substance mixing and drug product filling
• Assess whether existing IOQ/OQ documentation is robust enough
• Identify gaps between OQ and PQ
• Determine whether current qualifications can support performance qualification expectations
• Support product-specific mixing study needs, including evaluating mixing from an equipment qualification perspective
• Understand tank qualification, viscosity considerations, matrix/bracketing approaches, risk assessment, and how to identify, group, and mitigate validation gaps
• Support smoke study execution in an aseptic processing environment
• Drive execution, guide internal resources, manage execution, and keep the validation effort moving forward

Requirements

• Bachelor's degree in Engineering, Science, Life Sciences, or related technical discipline preferred
• Validation execution experience in a pharmaceutical, biotech, or aseptic manufacturing environment
• Equipment qualification experience
• Strong understanding of IOQ/OQ/PQ expectations
• Ability to perform gap assessments
• Tank qualification experience
• Mixing study experience or strong understanding of equipment-based mixing qualification
• Aseptic processing experience
• Smoke study experience or strong understanding of smoke study execution
• Ability to support protocol execution and documentation
• Ability to assess whether qualification packages are robust enough
• Ability to identify validation gaps and recommend mitigation strategies
• Ability to handle a strong personality and drive work forward without being timid