Validation Engineer

Katalyst CRO; Raleigh (NC); In loco; USD 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

Katalyst CRO is seeking validation consultants for a 9-month onsite project in South Carolina. The role focuses on validation execution and gap assessments across equipment, tank, and mixing studies, with emphasis on aseptic processing and aseptic technique.

The lead consultant will drive the project, guide internal resources, and ensure timely progression of validation activities. Responsibilities include evaluating IOQ/OQ documentation, bridging gaps to PQ, and advising on robust qualification

Competenze

• Bachelor's degree in Engineering, Science, Life Sciences, or related technical discipline preferred.
• Hands-on validation experience in pharma/biotech environments are a plus.
• Experience supporting IOQ/OQ/PQ activities and gap assessments is required.

Mansioni

• Support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument qualification.
• Drive project execution, guide internal resources, and maintain progress on validation deliverables.
• Assess IOQ/OQ documentation for robustness and identify gaps between OQ and PQ.
• Provide guidance on validation strategies and mitigation of identified gaps.

Conoscenze

Validation execution

Gap assessment

Project leadership

Aseptic processing

Tank qualification

IOQ/OQ/PQ

Mixing study

Documentation

Formazione

Bachelor's degree in Engineering or Life Sciences

Descrizione del lavoro

• Client is seeking validation consultants to support a 9-month minimum onsite project in South Carolina. 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. The team needs to 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.
• The consultants will also support product-specific mixing study needs, including evaluating mixing from an equipment qualification perspective. This includes understanding tank qualification, viscosity considerations, matrix/bracketing approaches, risk assessment, and how to identify, group, and mitigate validation gaps.
• The team will also support smoke study execution in an aseptic processing environment. The site has a tunnel and two lyophilizers, so candidates should understand aseptic technique, equipment operation, and how to drive execution as a validation representative.
• This role is execution-heavy, but the client also needs consultants who can perform gap assessments and provide guidance on validation strategies. The lead consultant should be able to drive the project, guide internal resources, manage execution, and keep the validation effort moving forward.

Responsibilities

• Client is seeking validation consultants to support a 9-month minimum onsite project in South Carolina. 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. The team needs to 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.
• The consultants will also support product-specific mixing study needs, including evaluating mixing from an equipment qualification perspective. This includes understanding tank qualification, viscosity considerations, matrix/bracketing approaches, risk assessment, and how to identify, group, and mitigate validation gaps.
• The team will also support smoke study execution in an aseptic processing environment. The site has a tunnel and two lyophilizers, so candidates should understand aseptic technique, equipment operation, and how to drive execution as a validation representative.
• This role is execution-heavy, but the client also needs consultants who can perform gap assessments and provide guidance on validation strategies. The lead consultant should be able to drive the project, 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. Equivalent hands-on validation experience can be considered.

Include Must Have

• 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.