Validation Manager (Design Transfer & Qualification) 12 months contract
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Job Description
About the Role We are seeking an experienced Validation Manager to support design transfer and validation activities within a highly regulated manufacturing environment.
The successful candidate will be responsible for planning, executing, reviewing, and documenting validation activities to ensure compliance with regulatory requirements, company quality standards, and internal Standard Operating Procedures (SOPs).
This is an excellent opportunity for a seasoned validation professional with strong hands-on experience in qualification and validation activities across facilities, equipment, manufacturing processes, and computerized systems.
Key Responsibilities
Support design transfer activities, including validation and qualification of: Facilities Equipment Utilities Materials Manufacturing processes Cleaning processes Computerized systems Ensure all validation activities are appropriately planned, executed, documented, and completed in compliance with regulatory requirements and internal SOPs.
Review and approve validation protocols, reports, and supporting documentation to ensure accuracy, completeness, and regulatory compliance. Coordinate with cross-functional stakeholders to support project timelines and validation deliverables.
Maintain accurate and organized validation records to support regulatory inspections, audits, and quality system requirements. Investigate validation-related issues and support the implementation of corrective and preventive actions where required.
Ensure compliance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (cGDP), and ALCOA+ data integrity principles.
Requirements
Bachelor's Degree in Engineering, Science, or a related discipline. Minimum 10 years of hands-on experience in validation within the pharmaceutical, medical device, biotechnology, or related regulated industry. Strong experience in qualification and validation of facilities, equipment, utilities, manufacturing processes, cleaning processes,