GMP Validation Lead (IQ/OQ/PQ) - Life Sciences

Katalyst-Healthcares-; Boston (MA); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Creative Solutions Services, LLC is seeking an experienced Validation Specialist to support GMP/GxP validation activities in a regulated environment. You will plan, develop, execute, and document validation and qualification activities across equipment, facility, utility, and process systems, ensuring compliance with FDA regulations and industry standards.

The role requires hands-on IQ, OQ, and PQ expertise, strong technical writing, and collaboration with Engineering, Quality, Manufacturing,

Qualifikationen

• 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

Aufgaben

• 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 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

Kenntnisse

IQ/OQ/PQ protocols

Validation planning & execution

GMP/GxP compliance

Technical writing

Cross-functional collaboration

Risk assessments

Jobbeschreibung

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 inValidationwithin 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