Job Title: Validation Manager

Work Location: Bucks County, PA

Summary:

The Validation Manager is responsible for overseeing validation programs for facilities, utilities, equipment, and processes, ensuring compliance with regulatory and quality standards. This role manages planning, execution, and documentation of commissioning, qualification, and validation activities, with a focus on sterile manufacturing systems and process readiness.

Responsibilities:

• Develop and maintain validation master plans, protocols (IQ/OQ/PQ), and summary reports in accordance with regulatory and quality requirements.
• Lead validation activities for autoclaves, dehydrogenation tunnels, lyophilizers, cleanrooms, and other critical sterile manufacturing systems.
• Oversee validation schedules, personnel assignments, and project timelines to support operational objectives.
• Compile, interpret, and report commissioning and qualification data, ensuring clear and compliant documentation.
• Troubleshoot and assess the impact of deviations, equipment changes, and atypical conditions on validation activities.
• Provide scientific and technical guidance for the validation of new or modified GMP processes and equipment.
• Ensure all validation activities comply with internal policies, safety standards, and cGMP documentation practices.
• Support ongoing requalification efforts and continuous improvement of validation processes across the site.

Qualifications:

• Bachelor’s degree in engineering, life sciences, or a related technical field (advanced degree preferred).
• 7+ years of progressive validation experience in a GMP pharmaceutical or biopharmaceutical environment, including at least 1 year in a supervisory or project leadership role.
• Strong knowledge of cGMPs, GDPs, and regulatory requirements related to qualification and validation (IQ/OQ/PQ).
• Hands-on experience with autoclave qualification is required; experience with tunnel, lyophilization, and terminal sterilization validation is strongly preferred.
• Demonstrated expertise in GMP cleaning validation, process validation, and equipment validation.
• Excellent analytical, problem-solving, and data interpretation skills with strong attention to detail.
• Ability to manage multiple validation projects simultaneously in a fast-paced, regulated environment.
• Strong communication and leadership skills to effectively oversee validation teams and projects.

Published Category: Quality & Validation