Validation Specialist

Support validation activities for manufacturing equipment, facilities, utilities, processes, and computerized systems in accordance with cGMP and applicable regulatory requirements. This role is responsible for assisting with the development, execution, review, and maintenance of validation documentation and activities to support compliant and reliable operations. The Validation Specialist will work cross-functionally with Quality, Operations, Engineering, IT, and other departments to support system lifecycle activities, continuous improvement, and inspection readiness.

Experience with computerized system validation (CSV) is required.

• Supports validation activities associated with manufacturing equipment, utilities, facilities, processes, and computerized systems.
• Assists in the preparation, execution, review, and revision of validation protocols and reports, including IQ, OQ, PQ, and CSV deliverables, as applicable.
• Authors, reviews, and maintains validation documentation such as validation plans, protocols, summary reports, traceability matrices, and risk assessments.
• Participates in validation lifecycle activities for equipment and computerized systems, including requirements review, testing, discrepancy resolution, and final documentation.
• Supports computerized system validation activities, including development of user requirements, risk assessments, test scripts, and validation summary documentation.
• Coordinates with cross-functional teams to support validation project timelines, testing activities, and document completion.
• Assists with execution of equipment qualification activities, including support for FAT/SAT, commissioning, and startup activities, as applicable.
• Supports process validation activities and data collection, trending, and analysis for manufacturing and customer projects.
• Participates in deviation investigations, impact assessments, CAPA, and change control activities related to validation systems and processes.
• Help ensure validation activities are completed accurately, on time, and in accordance with internal procedures and regulatory expectations.
• Supports audit and inspection readiness by maintaining organized, complete, and compliant validation documentation.
• Collaborates with internal stakeholders to support implementation of new systems, equipment, and process improvements.
• Maintains working knowledge of current validation practices, industry guidance, and regulatory requirements relevant to pharmaceutical manufacturing and computerized systems.

• Bachelor’s Degree in Engineering, Life Sciences, or a related scientific discipline is required.
• Requires 3–5 years of experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments with direct experience supporting validation activities.
• Experience with computerized system validation (CSV) is required.
• Experience in equipment qualification, process validation, or utility/facility qualification in a cGMP environment is required.

• Working knowledge of equipment, process, facility, utility, and computerized system validation principles.
• Experience supporting CSV lifecycle activities, including requirements, risk assessment, testing, and documentation.
• Familiarity with cGMP requirements, FDA regulations, data integrity expectations, and applicable industry guidance.
• Ability to author and review validation documents with attention to detail and compliance.
• Understanding of deviation, CAPA, change control, and risk management processes.
• Strong organizational and communication skills with the ability to work effectively across functions.
• Ability to manage multiple assignments and meet timelines in a regulated environment.
• Analytical thinking and problem-solving skills with the ability to identify issues and support practical solutions.
• Proficiency in Microsoft Office applications and ability to work within electronic quality/document management systems.
• Willingness to learn and develop technical expertise across validation disciplines.

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In Office Role:4 days in office in Cranbury, NJ…