Description
Commissioning Manager required to join a sterile pharmaceutical company in Ireland.
The Commissioning manager will work in the areas of Commissioning and Qualification of bio pharmaceutical manufacturing equipment and processes.
Role:
. Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
. Perform systems and P&ID Walkdowns, commission equipment, and provide Equipment Turnover Packages (ETOPs)
. Write and execute Factory Acceptance Tests (FATs), Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and cycle development protocols including development of final reports
. Assist the project lead in the delivery and project management processes required to complete the project within timeline and budget.
. Promote cGMP and regulatory compliance into assigned projects
. Review and modification of standard operating procedures (SOPs) for various equipment
. Document, monitor, and report on project deliverables
. Manage project documentation such as protocols, reports, calibration certificates, and process trends.
. Acting as a Commissioning System Owner' for a given system
. Facilitating and expediting construction handover/mechanical completion
. Liaising with/co-ordinating vendors, contractors and the site team to complete all scope of works
. Ensuring the installation and operation of your equipment/system meets project and client requirements
Requirements:
. BS or MS in Engineering or related discipline
. 5+ years in validation, quality systems, operations, engineering or any combination there of
. Experience in multiple GMP validation disciplines (process equipment, utility, automation, computer systems, sterilization) with advanced technical knowledge
. Knowledge of Validation Lifecycle approach (URS, FRS, FAT/SAT, Commissioning Protocols, etc) guidelines, international regulatory requirements and standards
. Ability to relate with people at all levels within an organization, including diverse cultures
If this is you please apply today.