The Validation Engineer is accountable for meeting deadlines in a fast-paced environment by developing Validation strategies, plans and documentation with the Director. This team member must also develop resource plans across multiple groups to meet deadlines and key milestones. The Validation Engineer works collaboratively with multiple departments to accomplish compliance. The Validation Engineer provides technical support to the appropriate groups of the organization and executes major Validation projects. Validation responsibilities include, but are not limited to, factory acceptance tests, commissioning, installation qualification, operational qualification, performance qualification, and re-qualification program. Additionally, smoke study experience is preferred.
Development of Validation documentation such as specifications, plans, protocols, risk assessments, reports, etc.
Development of this documentation to ensure compliance with GMP standards, corporate policies, FDA, EMA and other regulatory bodies.
Work closely with the PD, Operations and Quality groups to support the ongoing transfer, development, and overall production at the Matica facility.
Bachelors degree in Life Science, Engineering, Quality Management or related discipline preferred. Commensurate experience considered on a case-by-case basis.
3-5 years in direct job-related experience in GMP facility regulated by CBER, CDER
Working knowledge of; Aseptic processes, smoke study process, facilities and utilities construction for GxP initiatives, environmental control processes and procedures.