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The mission of the Engineering Validation Department is to provide documented evidence that the Performance Qualifications (PQ) of manufacturing equipment and systems involved in commercial drug products produced at the Allston Landing Facility perform in a qualified and reproducible manner and comply with the diverse regulatory requirements necessary for product release on a global scale. Moreover, Engineering Validation's scope of work also includes CIP, SIP and Autoclave cycle development as well as Performance Qualification of the same. The deliverables of the Engineering Validation Department include approved Final Reports for Qualification studies. These reports, and the protocols which drive them, are made available to the world-wide regulatory agencies via inclusion within regulatory filings, and during audits and inspections of the Allston Landing Facility.
The Manager Validation reports to the Senior Director Engineering and Facilities and manages a validation group responsible for the management, development and execution of DQ, IQ, OQ, PQ, and PV activities. Furthermore, the Manager Validation may act as a back up to the Senior Director Plant Engineering as necessary.
The Manager Validation shall be responsible for developing validation as well as integrated commissioning and qualification plans and reviewing and approving commissioning and validation documents in accordance with current GMPs. This individual will determine and develop approaches to resolve complex validation issues and working closely with Quality Assurance Managers to address deviations as well as recommend and implement corrective and preventative actions.
The Manager Validation must possess excellent verbal and written communication skills and the ability to communicate validation requirements, timelines, and resource needs to management. The Manager Validation will work closely with the project team members, such as Manufacturing, Engineering, and the Quality Assurance, to incorporate the appropriate elements of quality and production into validation strategies.
Additional responsibilities include overseeing training and development of staff to ensure compliance with Genzyme procedures and regulatory expectations, resource forecasting and input to department budget estimates, improving functional effectiveness, development of department goals, and presentation of validation documents and strategies to Senior Management and regulatory agencies. Some travelling may be required between Mass Biologics facilities. This position requires conducting duties during 2nd or 3rd shifts when necessary (typically 10-20% of the time). Some travelling may be involved.
Genzyme's leaders motivate, inspire, build, and retain highly effective manufacturing teams while managing for high performance and developing others. They are versatile learners and courageous decision makers.
Leading the Business
Genzyme's leaders are effective operating in an evolving, complex and dynamic
environment, providing clear direction and instruction to supervisors and direct reports, and continuously looking internally and externally for best practices and areas for improvement.
Delivering to Customers
Genzyme's leaders understand patient and customer needs and build relationships as required to meet manufacturing goals while continuously improving operations by setting high standards for the team so they may perform to a level of excellence.
· Minimum of 10 years of experience in the industry (8 years validation)
· A minimum of 4 years of experience in a supervisory or management role
· Bachelor's or Master's Degree in Engineering or Science
Strong leadership and facilitation skills
· Energetic in the pursuit of improved processes and ultimately improved performance
· Natural influencer, adaptable, flexible as well as a pragmatically minded problem solver
· Competent technical knowledge of bio-pharmaceutical plants and manufacturing processes
· Innovative and capable of developing alternative solutions to issues at hand
· Good communication skills at organization, team, and individual levels
· Working knowledge of GMPs, ICH Q8, Q9, Q10 and other international regulatory requirements
· Application of risk based approach to validation (FMEA, PHA, etc)
· Knowledge of Validation Lifecycle Approach, such as ASTM E-2500
· Investigation/ troubleshooting of validation problems
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