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Senior Validation Engineer Manager
2 months ago
Job Summary
Bristol-Myers Squibb is seeking a highly skilled Senior Validation Engineer Manager to join our team. As a key member of our Validation Engineering organization, you will be responsible for ensuring the successful implementation of manufacturing and laboratory equipment at multi-use sites.
Key Responsibilities
- Maintain qualified equipment systems in compliance with policies, guidelines, and procedures.
- Execute and/or lead 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 are 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.
- Provide 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.
- Lead 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.
- Maintain 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.
Requirements
- Knowledge of engineering generally attained through studies resulting in a Bachelor of Science degree in Chemical Engineering, Mechanical Engineering, related discipline, or its equivalent is required.
- A minimum of 7+ years relevant experience with process equipment, computer systems, manufacturing process control systems (automation), and laboratory instrumentation in an FDA-regulated manufacturing facility.
- Minimum of 4 years experience in equipment, facility, or utility qualification.
About Us
Bristol-Myers Squibb is a global biopharmaceutical company dedicated to transforming patients' lives through science. Our unique vision, inspiring work, and inclusive culture empower our employees to apply their individual talents and unique perspectives to create a better future for all.
