Description
The Senior Manager of Validation Engineering is responsible for understanding and implementing validation requirements for a sterile injectables manufacturing and packaging facility. The ideal candidate has practical experience in qualification and validation as well as leadership experience. The Senior Manager of Validation Engineering will partner with internal and external customers to meet the needs of client projects, capital expansion projects, and maintenance of the validated state. They will possess a demonstrated ability to influence positive outcomes and have direct reporting authority. Additionally, they must thoroughly understand and be able to adapt to the changing needs of a manufacturing environment.
Essential Job Functions:
• Lead the Validation department with Commissioning, Qualification and Validation (CQV) activities for utilities, equipment and associated systems. This includes, but is not limited to, clean utilities, steam sterilization and depyrogenation, manual and automated cleaning, filling, inspection, packaging and labeling, etc.
• Review and approve CQV lifecycle documentation.
• Support and oversee development and maintenance of validation lifecycle documents, document templates, validation strategies and policies.
• Support site change management program, including risk assessment and evaluation of required testing and GMP activities.
• Assess risks involved in processing steps related to equipment, developing and/or reviewing validation requirements and design deliverables.
• Interact with clients to provide validation support including, but not limited to, customer product launches, new equipment qualifications, audits, etc.
• Review and provide technical expertise to regulatory filings, and support health authority inspections.
• Support and provide validation oversight for capital expansion projects/build outs. This includes development and maintenance of CQV schedule for capital projects.
• Engage in a cross functional team and work closely with other supporting groups including Engineering and Operations to support and monitor validation and process improvement efforts.
Special Job Requirements:
• Bachelor's degree or higher in a STEM discipline, preference in an engineering or life science discipline
• 10+ years of experience in Validation or related discipline
• 8+ year GMP experience required or other regulated industry
• 5+ years of supervisory experience
• Physically capable of working onsite
Additional Preferences:
• Aseptic Fill and Finish Experience
• Experienced with cleaning validation, steam and dry heat sterilization and depyrogenation, inspection and packaging
• Strong working knowledge of regulatory requirements, risk-based guidance, and industry expectations
• Continuous improvement certification, i.e., Lean Six Sigma, or similar practices
