Manager, Senior Validation Engineer

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The Manager, Sr. Validation Engineer I supports the successful implementation of manufacturing and laboratory equipment at multi-use sites through interaction with internal customers and external service providers.

The incumbent is tasked with qualifying new equipment facilities, utilities and maintaining equipment systems in a qualified / validated state according to established policies and procedures. The individual participates in projects and ongoing work activities of medium to high complexity.  With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of moderate scope. As a senior team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.

Key Responsibilities:

1. Maintains qualified equipment systems in compliance with policies, guidelines and procedures:

• Executes and/or Leads installation, commissioning activities of area specific process equipment, validation of SIP/CIP processes, qualification of environmental chambers and qualification of critical process utility systems.

• Ensure periodic reviews and requalification is being performed in accordance with schedule.

• Manage and allocate resources responsible for capital project teams performing validation activities of new equipment and standalone/enterprise laboratory computerized systems and/or changes to existing equipment and standalone/enterprise computerized systems with oversight of department management.

• Author and review the Development/Review of SOPs, WPs, test protocols, validation deliverables, plans and policies as needed.

• Execute work arising from change strategy, risk assessment, testing and compliance gaps. 

• Provides Single Point of Contact (SPOC) on all validation activities for a specific manufacturing area in Biologics or Cell Therapy or its supporting areas, working with designated peers to create a team/triage environment.

• For novel projects, this individual works with Quality Assurance, consulting Validation management as needed, to establish appropriate validation methodologies.

• Leads a portfolio of medium to complex validation projects under strict deadlines to ensure stakeholder success and bulk drug supply. Leads projects while serving as an individual contributor of technical work and a point of contact for project stakeholders and cross-functional team members.

• Maintains familiarity on BMS directives and industry guidelines on qualification/validation. Provides, in addition to operations support, internal compliance and/or efficiency improvement efforts within department for more complex processes.

2. Promotes and provides excellent customer service and support

• Regularly reviews, prioritizes, and promptly responds to end user equipment qualification and support requests.

• Provides technical support and guidance on equipment qualification and validations issues.  Interfaces with customers to ensure all expectations are being met.

3. Communication and Management of Timelines

• Executes multiple medium to highly complex projects and priorities across the many portfolios of capital projects that the Validation Engineering organization serves.