Validation Specialist

Katalyst CRO; Boston (MA); On-site; USD 110,000 - 170,000; Full time

Job summary

Katalyst CRO is seeking an experienced Validation Specialist to lead and execute GMP-compliant validation activities across equipment, facility, utility, and process systems in a regulated environment.

You will develop IQ/OQ/PQ protocols, draft reports, manage risk assessments and CAPA, and collaborate with Engineering, Quality, Manufacturing to ensure FDA/GxP adherence.

Qualifications

• 10 years of validation experience in Pharma, Biotech, or Life Sciences.
• Hands-on IQ, OQ, and PQ experience.
• 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.

Responsibilities

• Plan, develop, execute, and document validation and qualification activities per GMP.
• Develop, review, and execute IQ, OQ, and PQ protocols and prepare validation reports.
• Support equipment, facility, utility, and process validation throughout the lifecycle.
• Participate in FAT, SAT, commissioning, qualification, and validation activities.
• Collaborate with Engineering, Quality Assurance, Manufacturing, and Validation teams to ensure validation success.
• Develop and maintain validation documentation: protocols, reports, test scripts, traceability matrices, and validation plans.
• Identify, investigate, and document deviations and CAPA, and support corrective actions.
• Perform and document risk assessments in support of validation activities.
• Ensure validation activities comply with GMP/GxP and FDA requirements.
• Review engineering and technical documentation for qualification suitability.

Skills

Validation expertise

GxP knowledge

Technical writing

Cross-functional collaboration

Documentation skills

Job description

Job Summary

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.

Education & Experience

• 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