You prepare and execute validation protocols involving facilities equipment, utilities and associated automation . In addition you prepare, review and approve (as required) SOPs , validation deviations , change controls , validation summary reports and associated documentation.
You will become experienced in site Validation Program , company global directives, procedures and other related compliance / regulatory documents.
You are the primary contact for validation related issues arising during validation activities (including protocol execution ) on site.
You investigate deviations and non-conformances to determine impact on product quality , validation status and associated compliance requirements.
You review and approve Change Controls applicable to any system that needs to be qualified.
You will work with cross functional teams to perform deviation root cause analysis and formulate corrective / preventative actions (CAPA).
You will support commissioning activities, including review of commissioning plans, procedures, turnover packages etc.
You must have experience of bio pharmaceutical manufacturing processes , equipment and qualification / validation requirements.
You understand industry regulations and guidelines particularly those relating to facility, utility and equipment validation .
You bring expertise on one or more of the following : Upstream Processing, Downstream Processing, Clean Utilities, Computer System Validation.
Ideally you have knowledge of DCS, MES or PLC systems.
As a Validation Engineer you are responsible for the performance and reporting on validation activities related to bio pharmaceutical Facilities, Utilities and Equipment (FUE) and associated systems (e.
g. automation). In addition you are planning, coordinating and driving validation activities from initiation to completion.
As a primary decision maker for assigned validation activities you will investigate deviations, risk and impact assessment together with other activities.
You report to the Senior Manager, Equipment & Systems Validation.