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
Numbers & Facts
Location
Boston, MA
Skills
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Change Controlunmatched
Commissioningunmatched
Corrective Actionunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cross-Functionalunmatched
FDA Requirementsunmatched
GMP (Good Manufacturing Practices)unmatched
GxPunmatched
Industry Standardsunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Process Validationunmatched
Quality Assuranceunmatched
Regulatory Complianceunmatched
Risk Analysisunmatched
Risk Managementunmatched
Technical Writingunmatched
Test Scriptsunmatched
Traceabilityunmatched
Validation Documentationunmatched
Validation Planunmatched
Writing Skillsunmatched
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