We are seeking an experienced and detail-oriented Mid-Level Validation Specialist to join our team. The Validation Specialist will play a key role in ensuring that all processes, systems, and equipment within the client organization are commissioned, qualified, and validated in compliance with regulatory requirements and industry standards. Experience with Cell Therapy equipment qualification is a plus.
Responsibilities:
- Develop and execute commissioning, qualification, validation protocols for equipment, facility systems, and utilities. These protocols include Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Conduct risk assessments and impact analyses.
- Work with cross-functional teams to coordinate and carry out CQV activities.
- Develop CQV documentation, including plans, test protocols, summary reports, and traceability matrices, ensuring technical accuracy and compliance with regulatory requirements.
- Investigate and address deviations encountered during qualification/validation activities, working closely with relevant stakeholders to identify root causes and implement corrective actions.
- Provide technical guidance and expertise on qualification/validation principles, requirements, and best practices to internal stakeholders.
- Stay up-to-date with regulatory guidelines, industry trends, and best practices related to validation and quality assurance.
Qualifications:
- Bachelor's degree in Engineering, IT, Science, or related field. Advanced degree preferred.
- Minimum of 3 years of experience in CQV and/or CSV within the pharmaceutical, biotechnology, cell therapy or medical device industries.
- Experience with Cell Therapy equipment (cell counters, cell processing systems, cell analyzers, bioreactors, etc.) qualification is a plus.
- Strong understanding of validation principles and methodologies, including risk-based validation approaches.
- Knowledge of regulatory requirements, including FDA, EMA, and ICH guidelines.
- Excellent analytical, problem-solving, and communication skills.
- Ability to work effectively in a team environment and collaborate with cross-functional teams.
Work Authorization:
Please note that unfortunately at this time Sokol GxP Services does not provide H1B visa sponsorship or hire candidates requiring visa sponsorship. Applicants must have the legal right to work in the United States without needing sponsorship.