Description
The PositionThe Senior Validation Engineer/Sr. Technical Manager position is responsible for defining validation strategy, and coordinating Validation activities required to complete assigned validation projects.
Responsibilities:
- Responsible for oversight and performance of Commissioning and Qualification of equipment, utility systems, automation systems, processes and facilities
- Prepares/Updates Validation Master Plans, Project Plans, and Protocols; Commissioning Plans, performs testing, collects samples, analyzing test results, and prepares Commissioning and Qualification summary reports
- Leads efforts by representing the department on project teams and coordinates activities of Technology, Manufacturing, Quality, and other Vacaville groups required to manage projects
- Leads resolutions to regulatory observations through the CAPA system
- Leads the assessment for multi product risk as a result of introduction of new products to the existing manufacturing facility.
Requirements:
- Bachelors degree (Life Science, Engineering, Biology, Biochemistry)
- Minimum of eight years of direct validation experience with increasing levels of responsibility for a wide range of validation projects
- Thorough knowledge of validation principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory agency expectations and industry trends
- Strong technical writing, verbal communication, interpersonal and problem solving skills