Our client is looking for a Validation Engineer to join their growing team. The Validation Engineer will be responsible for providing commissioning, qualification, and validation support with regard to site facilities, utilities, equipment, processes, an/or systems. They will be responsible for their day-to-day activities including execution, protocol management, vendor management issues, deviations, corrections and remediation efforts for facility, utility, equipment, systems, and processes in support of personalized cell and gene therapy production and associated development & analytical processes through safe and compliant manufacturing and testing operations according to cGMP requirements.
No sponsorship or visa transfers available
Must currently reside within a commutable distance from King of Prussia, PA
Formal Training/Education:
- Bachelor's degree in science, engineering or equivalent technical discipline is required
- Minimum of 3 years relevant experience required in an aseptic manufacturing facility,
- preferably cell therapy, testing facility, quality assurance or manufacturing compliance
- Proven work experience in validation required or Current Good Manufacturing Practices (cGMP)
Primary Responsibilities:
- Participate in providing a planned, documented and managed approach to the commissioning, qualification testing of cGMP systems and equipment to include associated maintenance activities
- Operate independently in conducting assessments for quality events that impact CQV areas of responsibility. Conduct action planning reviews for quality events requiring validation input
- Authors, owns and executes CQV protocols, summary reports and data acquisition in compliance with CBM standard operational procedures and regulatory requirements
- Responsible for assigned CQV projects including core team representation, prioritization, tracking of commissioning/qualification tasks, and status reports to ensure on-time project delivery
- Understands existing system boundaries and assists CQV management with establishing any new system boundaries, scope of work and commissioning execution plans
- Supports the authoring of risk assessments, FMEAs, periodic qualifications, project plans, master plans and annual product reviews as assigned
- Supports quality investigations, CAPAs and corrections to supporting documentation as needed
- Participates in the creation, revision, and review of controlled documentation as it pertains to CQV processes and requirements
- Identify CQV areas and processes for continuous improvement opportunities
