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Validation Specialist
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
Mid level
3 weeks ago
- GMP
- GxP
- CAPA
- Technical Writing
3 weeks ago
We are seeking an experienced Validation Specialist to support validation activities in a GMP-regulated environment. The ideal candidate will have strong hands-on expertise in equipment, facility, utility, and/or process validation, including IQ, OQ, and PQ activities. This role will support validation lifecycle activities in a GMP/GxP-regulated environment, working closely with Engineering, Quality, Manufacturing, and Validation teams to ensure compliance with applicable FDA regulations and industry standards.
Roles and Responsibilities:
- Plan, develop, execute, and document validation and qualification activities in accordance with approved procedures and GMP requirements.
- Develop, review, and execute IQ, OQ, and PQ protocols and prepare comprehensive validation reports.
- Support equipment, facility, utility, and process validation activities throughout the validation lifecycle.
- Participate in FAT, SAT, commissioning, qualification, and validation activities for new and modified systems and equipment.
- Collaborate with Engineering, Quality Assurance, Manufacturing, and other cross-functional teams to ensure successful validation execution.
- Develop and maintain validation documentation, including protocols, reports, test scripts, traceability matrices, and validation plans.
- Identify, investigate, and document deviations and validation discrepancies, and support appropriate corrective and preventive actions (CAPA).
- Perform and document risk assessments in support of validation and qualification activities.
- Ensure validation activities comply with GMP/GxP requirements, FDA regulations, company procedures, and applicable industry standards.
- Review engineering and technical documentation to ensure requirements are suitable for qualification and validation.
- 10 years of experience in Validation within Pharma, Biotech, or Life Sciences
- Hands-on experience with IQ, OQ, and PQ
- Experience with equipment, facility, utility, or process validation
- Strong knowledge of GMP, GxP, and FDA regulations
- Experience developing and executing validation protocols and reports
- Experience with deviations, CAPA, change controls, and risk assessments
- Experience supporting FAT/SAT, commissioning, and qualification activities
- Strong technical writing and documentation skills
- Ability to work with Engineering, Quality, Manufacturing, and Validation teams
Validation Specialist · Katalyst Healthcares & Life Sciences