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.
• 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, including work with a tunnel and two lyophilizers.
• Drive execution as a validation representative, applying knowledge of aseptic technique and equipment operation.
• Perform gap assessments and provide guidance on validation strategies.
• Lead consultant: drive the project, guide internal resources, manage execution, and keep the validation effort moving forward.

The project is a 9-month minimum onsite engagement in South Carolina, 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. This role is execution-heavy.

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.

Nice To Have/A Plus

• Smoke study, tunnel, or lyophilizer experience (preference).
• Mixing study experience, especially with tanks, compounding, or formulation.
• FDA audit remediation or validation gap closure experience.
• Risk assessment, bracketing, or matrix validation strategy experience.