Onsite Validation Lead – Pharma Equipment & Aseptic Systems

Creative Solutions Services, LLC; Charleston (WV); On-site; USD 120,000 - 180,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Validation execution

IOQ knowledge

OQ/PQ knowledge

Tank qualification

Mixing study understanding

Aseptic processing

Smoke study execution

Gap assessments

Documentation support

Project leadership

Education

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

Equivalent hands-on validation experience

Job description

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.