Validation Manager
3 weeks ago
This is a critical role that oversees the validation program at the Bedford Site, ensuring compliance with current Good Manufacturing Practices (cGMP), ISO requirements, and ICH guidelines. The successful candidate will work closely with the Director of Engineering to define, administer, and continuously improve the site's validation programs.
Key Responsibilities- Develop and implement validation master plans (VMPs) and procedures to ensure compliance with regulatory requirements
- Manage the site's validation program, ensuring timely execution of all validation/re-validation requirements
- Author, execute, and summarize qualification and validation protocols
- Coordinate the investigation, impact assessment, and resolution of validation and re-validation non-conformances
- Establish key performance indicators (KPIs) in alignment with company, operational, and engineering goals
- Support new product and capital project teams by defining and coordinating commissioning and qualification requirements
- Provide technical advice on new equipment and modifications to existing equipment to ensure validation/qualification status is maintained
- Identify, assess, and mitigate operational and organizational risks
- Support the development of the department's annual operating budgets and analyze variances
- Bachelor's degree in engineering or life sciences or equivalent experience
- 5+ years of validation/engineering experience in pharmaceuticals or medical devices
- Expertise in FDA, EMA, and ICH qualification/validation requirements and creative risk-based approaches
- Demonstrated situational leadership skills and project management expertise
- Thorough understanding of key supporting quality systems, including change control, deviation/non-conformance, and CAPA
- Excellent analytical and problem-solving skills, coupled with strong presentation skills
- Excellent communication skills, both verbal and written
- Advanced degree or post-graduate coursework
- Working knowledge of Kaye Validator or equivalent thermal mapping systems
- Direct experience in commissioning and qualification of critical utility systems, critical process equipment, and computer systems
- Direct experience working in an aseptic formulation and fill manufacturing environment
- Strong knowledge of industry standards for sterility assurance in an aseptic manufacturing environment
- Solid understanding of quality risk management (QRM) principles and statistical concepts
- Subject matter expert on regulations and best practices pertaining to validation, including ISO 13485, GHTF Process Validation Guidance, and other applicable standards
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Senior Validation Manager
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Silicon Validation Expert
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Validation Engineer III
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Senior Validation Specialist
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Validation Specialist II
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Senior Validation Manager
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Senior Validation Engineer
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Verification and Validation Specialist
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Post Silicon Validation Engineer
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Biopharmaceutical Validation Engineer/Specialist
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