Validation Engineer

Katalyst-Healthcares-; Raleigh (NC); On-site; USD 83,000 - 124,000; Full time

Job summary

Creative Solutions Services, LLC is seeking validation consultants to support a 9-month onsite project in South Carolina. The team will perform validation execution and gap assessments tied to equipment qualification, IOQ/OQ/PQ, tank qualification, mixing studies, and aseptic technique.

Candidates must drive the project, guide internal resources, manage execution, and identify mitigation strategies for gaps in qualification packages, including smoke study execution in an aseptic processing

Qualifications

• Validation execution experience in pharmaceutical/biotech/aseptic manufacturing.
• Strong equipment qualification background (IOQ/OQ/PQ).
• Experience performing gap assessments and drafting mitigation plans.
• Tank qualification and mixing studies experience.
• Aseptic processing and smoke study exposure.
• Ability to drive protocols and document outcomes effectively.

Responsibilities

• Perform validation execution and gap assessments.
• Assess IOQ/OQ/PQ gaps and determine PQ readiness.
• Evaluate tank qualification and mixing study outcomes.
• Lead smoke study execution in aseptic environments.
• Guide internal resources to keep validation moving forward.

Skills

Validation execution

Equipment qualification

IOQ/OQ/PQ understanding

Gap assessment

Aseptic processing

Smoke study

Documentation

Project leadership

Education

Bachelor's degree in Engineering/Science/Life Sciences

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.

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.