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Validation Maintenance Manager
4 weeks ago
Validation Maintenance Manager
About the Role:As a Validation Maintenance Manager, you will provide leadership to the Validation Maintenance Program for annual requalification of GxP manufacturing equipment used for commercial production. You will develop a validation strategy to the site and global projects, oversee engineering validation, and sign off on commissioning, qualification/validation, and final report documents.
Key Responsibilities:- Assess, qualify, and validate equipment, critical systems, facilities, computerized systems, cleaning, and sterilization processes.
- Coordinate with manufacturing and production schedules to access equipment for requalification.
- Improve and adapt the Validation Maintenance Program processes to meet demands in the manufacturing facility.
- Lead and represent the respective validation elements to determine validation strategy and system validation requirements.
- Develop protocols, coordinate validation activities, prepare final reports, and assemble validation packages.
- Typically requires a BA or BS degree in engineering or science.
- Must have experience leading a team and project management skills.
- Prior experience with manufacturing processes, control systems, cleaning processes, process equipment, facilities, and GMP critical support systems is required.
- Prior experience interacting with the FDA and other regulatory agencies is a plus.
- Proficiency and leadership in pharmaceutical/biotech validation elements, including writing and executing protocols and standard operating procedures.
- Competitive salary and benefits package.
- Opportunity to work in a dynamic and innovative company.
- Chance to develop your skills and expertise in validation and manufacturing.
