Validation Engineer

Responsibilities

• Support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment qualification.
• Support a 9-month minimum onsite project in South Carolina driven by audit findings and identified gaps in the site's validation program.
• Focus primarily on 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, and determine whether current qualifications can support performance qualification expectations.
• Support product-specific mixing study needs, including evaluating mixing from an equipment qualification perspective.
• Apply understanding of 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.
• Understand aseptic technique, equipment operation, and how to drive execution as a validation representative, including for the site's tunnel and two lyophilizers.
• Perform gap assessments and provide guidance on validation strategies.
• Drive the project, guide internal resources, manage execution, and keep the validation effort moving forward as the lead consultant.

Requirements

• Bachelor's degree in Engineering, Science, Life Sciences, or related technical discipline preferred; equivalent hands-on validation experience can be considered.
• 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.