The opportunity
The Sr. Validation Lead role is responsible for ensuring the timely development, execution, approval, and completion of validation projects in support of a biologics manufacturing facility and associated laboratories. The Sr. Validation Lead will serve as project manager and lead validation engineer for validation deliverables and associated work product to ensure equipment, systems, and utilities are initially qualified and remain qualified for GxP use throughout their lifecycle against Teva and regulatory regulations.
The incumbent must be skilled in data integrity, good documentation practices, and manufacturing and laboratory equipment qualification protocols and executions.
The Sr. Validation Lead must have thorough knowledge and experience with global regulatory requirements for validation; including 21 CFR Part 11, Annex 1, and current GAMP5 guidelines.
The selected individual will be a key member of the Teva R&D organization that owns and operates a biologics manufacturing facility and supporting laboratory facilities.
The position is on-site and based in West Chester, PA.
Occasional travel to other global Teva or vendor sites may be required.
How you’ll spend your day
Essential Duties & Responsibilities:
• Represent validation in multi-disciplinary teams focused on commissioning and qualification activities.
• Serve as lead validation engineer and project manager on commissioning and qualification projects
o Responsible for completing projects to meet business needs with compliance against Teva procedures and regulatory requirements
o Support all aspects of the validation life cycle from design through operation and improvement to retirement, as required for all Teva Biologics validation functions
o Responsible for the preparation of validation documentation and execution of validation testing documentation
o Responsible for guiding project team members to quality, on time completion of deliverables
o Responsible for communicating with project stakeholders and Quality Assurance personnel to ensure collaboration across all job functions
• Perform review of validation documentation and provide feedback based on Teva local and corporate procedures
• Technically independent and maintains up-to-date knowledge of validation standards and regulatory compliance requirements.
• Ensure validation performed by vendors is complete and accurate, work with vendors for issue resolution, validation deviation reporting, and generate summary reports based on vendor protocol results
• Support the revalidation program
• Collaborate with other support services functions within the BOSS department: Automation Engineering, Process Engineering, Calibration/Maintenance, and Compliance to support the biologics manufacturing facility and laboratories
• Create, maintain, and review validation standard operating procedures
• Lead deviation investigations with application of root cause analysis tools and design/execute CAPA per Teva procedures.
• Ensure site alignment with corporate standards and cGMP guidelines
• Work independently and/or with subject matter experts to implement process improvements and optimize key validation and quality initiatives
• Support internal and external audits and assessments
• Provide support and training for validation team members and consultants
• Provide weekly and/or monthly project status reports to management
• Ensure training is up to date
