Lead Validation Engineer – GMP Equipment & Aseptic

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

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