Validation Engineer

Katalyst CRO; City of Rochester (NY); In loco; USD 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

Katalyst CRO is seeking validation consultants for a minimum 9-month onsite project in the United States. The role focuses on validation execution, equipment qualification, tank qualification, and mixing studies, with emphasis on aseptic technique and smoke study execution.

The ideal candidate will assess IOQ/OQ documentation, identify gaps between OQ and PQ, and determine whether current qualifications can support PQ expectations.

Competenze

• Bachelor's degree in Engineering, Science, Life Sciences, or related technical discipline preferred; equivalent hands-on validation experience considered.
• Must have validation execution experience in pharmaceutical, biotech, or aseptic manufacturing environments.
• Strong understanding of IOQ/OQ/PQ expectations and ability to perform gap assessments.
• Tank qualification and mixing study experience or strong understanding of equipment-based mixing qualification.
• Experience with aseptic processing and smoke studies; capable of driving validation execution as a representative.

Mansioni

• Support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment qualification.
• Assist in evaluating IOQ/OQ documentation, identify gaps between OQ and PQ, and determine whether current qualifications support PQ expectations.
• Support product-specific mixing studies from an equipment qualification perspective and assess viscosity, matrix/bracketing, and risk-related gaps.
• Drive execution, guide internal resources, and keep the validation effort moving forward as a validation lead.

Conoscenze

Validation execution

Equipment qualification

IOQ/OQ/PQ

Gap assessments

Aseptic processing

Smoke study

Documentation

Formazione

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

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.