Validation Engineer

Katalyst-Healthcares-; Charleston (WV); In loco; USD 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

Creative Solutions Services, LLC is seeking validation consultants for a 9-month onsite project in the Southeast to support equipment, tank, and process validations, including IOQ/OQ/PQ documentation gaps and mixing studies.

The role emphasizes execution with gap assessments, project leadership, and guidance on validation strategies in an aseptic environment, with strong emphasis on tank qualification and smoke study execution.

Competenze

• Validation execution experience in 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 understanding of equipment-based mixing qualification.
• Aseptic processing experience.
• Smoke study experience or 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 mitigation strategies.
• Ability to handle a strong personality and drive work forward without being timid.

Mansioni

• Support validation execution and gap assessments tied to equipment and process qualifications.
• Assess IOQ/OQ documentation robustness and gaps between OQ and PQ.
• Support product-specific mixing study needs and tank qualification considerations.
• Perform smoke study execution in aseptic processing environment.
• Lead the project, guide internal resources, manage execution, and move validation forward.

Conoscenze

Validation execution

IOQ knowledge

OQ/PQ knowledge

Tank qualification

Mixing study understanding

Aseptic processing

Smoke study execution

Gap assessments

Documentation support

Project leadership

Formazione

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

Equivalent hands-on validation experience

Descrizione del lavoro

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.