Validation Engineer

Katalyst CRO; Charleston (WV); On-site; USD 120,000 - 150,000; Full time

Job summary

Katalyst CRO is seeking validation consultants for a minimum 9-month on-site project in South Carolina. You will support validation execution and gap assessments across equipment and tank qualification, with emphasis on IOQ/OQ/PQ readiness and aseptic processing.

The role requires a strong understanding of validation strategies, the ability to drive the project, and experience in mixing studies and smoke studies within a pharmaceutical environment.

Qualifications

• Bachelor's degree or equivalent hands-on validation experience preferred.
• Experience supporting validation activities in pharmaceutical, biotech, or aseptic manufacturing environments.
• Strong knowledge of IOQ/OQ/PQ expectations and documentation.

Responsibilities

• Execute validation activities and gap assessments tied to equipment qualification and tank qualification.
• Evaluate mixing studies and assess equipment-based mixing qualification from IOQ to PQ.
• Support smoke study execution in aseptic processing environments and ensure proper aseptic technique.
• Identify gaps in qualification packages and provide mitigation recommendations to move the project forward.
• Drive project execution, coordinate with internal resources, and maintain project momentum.

Skills

Validation execution

Equipment qualification

IOQ/OQ/PQ concepts

Gap assessments

Tank qualification

Mixing study

Aseptic processing

Smoke study execution

Documentation

Mitigation strategies

Assertive project leadership

Education

Bachelor's degree in Engineering, Science, Life Sciences, or related technical discipline

Job description

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.

Education 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.