Validation Specialist

Job Description

Position Summary

We are seeking a detail-oriented Validation Specialist to support validation and qualification activities within a pharmaceutical manufacturing environment. This individual will help ensure that manufacturing equipment, utilities, facilities, computerized systems, and processes are qualified and validated in accordance with applicable regulatory requirements, Good Manufacturing Practices (GMP), and company quality standards.

The Validation Specialist will work cross-functionally with Quality Assurance, Engineering, Manufacturing, Quality Control, and other technical teams to develop and execute validation protocols, review documentation, investigate discrepancies, and maintain the validated state of manufacturing systems and processes.

The ideal candidate has experience in pharmaceutical or biotechnology manufacturing, a strong understanding of validation principles, and the ability to manage documentation and projects in a regulated environment.

Key Responsibilities

Validation & Qualification

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• Develop, review, and execute validation and qualification protocols, reports, and supporting documentation.
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• Support equipment, facility, utility, and manufacturing process qualification activities.
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• Assist with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.
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• Support process validation, cleaning validation, and sterilization validation, as applicable.
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• Participate in commissioning, qualification, and validation (CQV) activities for new or modified equipment and systems.
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• Ensure validation activities are completed according to approved procedures, project timelines, and regulatory expectations.
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• Maintain the validated state of equipment, systems, and processes through periodic reviews and requalification activities.
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GMP Compliance & Documentation

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• Ensure validation documentation complies with applicable GMP requirements, company procedures, and regulatory expectations.
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• Prepare, review, and maintain protocols, test scripts, technical reports, and validation summary reports.
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• Ensure validation records are accurate, complete, traceable, and inspection-ready.
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• Support change control activities and assess the impact of equipment, process, facility, and system changes on the validated state.
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• Assist with deviations, investigations, corrective and preventive actions (CAPA), and remediation activities related to validation.
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• Support internal audits, regulatory inspections, and quality system reviews as needed.
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Cross-Functional Collaboration

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• Partner with Quality Assurance, Engineering, Manufacturing, Quality Control, and Facilities teams to support validation projects.
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• Coordinate validation execution activities, including testing, data collection, documentation, and issue resolution.
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• Communicate project status, risks, discrepancies, and schedule impacts to relevant stakeholders.
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• Provide technical support and guidance regarding validation requirements and documentation practices.
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Continuous Improvement

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• Identify opportunities to improve validation processes, documentation practices, and project execution.
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• Support risk assessments and validation strategies using a science- and risk-based approach.
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• Assist with the development and maintenance of validation plans, procedures, and standard operating procedures (SOPs).
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• Support the implementation of industry best practices and evolving regulatory expectations.
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Required Qualifications

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• Bachelor's degree in Engineering, Chemistry, Biology, Pharmaceutical Sciences, or a related scientific or technical discipline preferred; equivalent relevant experience may be considered.
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• Typically 2–5 years of experience in validation, qualification, quality assurance, engineering, or a related function within pharmaceutical, biotechnology, or regulated manufacturing.
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• Working knowledge of GMP requirements and pharmaceutical manufacturing practices.
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• Experience preparing, executing, or reviewing validation protocols and reports.
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• Familiarity with IQ, OQ, and PQ documentation and execution.
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• Strong technical writing, documentation, organizational, and problem-solving skills.
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• Ability to manage multiple priorities and collaborate effectively with cross-functional teams.
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• Proficiency with Microsoft Office and electronic quality or document management systems.
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