Reporting to the Commissioning & Qualification Manager, the Commissioning & Qualification Engineer will be responsible for developing, executing and gaining post approval for Factory Acceptance Test (FAT) documents Commissioning Test Plans (CTP's), Installation Operational Qualification (IOQ) Protocols, Performance Qualification (PQ) Protocols and associated reports.
The Commissioning & Qualification Engineer will work closely with different Project Engineers, Project Managers, Construction Management, Facilities and Manufacturing.
- Update the SLIA as required.
- Prepare Tag list for each system with Project Engineer
- Prepare the CLIA for each system with Project Engineer
- Preparation of Factory Acceptance Test Protocols (FAT's), Commissioning Test Plans (CTP's), Installation & Operational Qualification Protocols (IOQ's) and Performance Qualification (PQ) Protocols.
- Reviewing the FAT, CTP, IOQ & PQ Protocols prior to execution
- Identifying appropriate personnel to review and approve the test Protocols pre & post execution
- Witness execution of leveraged tests in FAT's & CTP's
- Ensuring that leveraged FAT & CTP testing is completed correctly.
- Execute 100% review of all test records & reportable results for accuracy, completeness & compliance with pre-established acceptance criteria
- Raise Commissioning Change Notifications (CCN's) for any changes that arise during execution of the FAT, CTP or IOQ tests
- Organise all necessary Vendor and craft support required to execute tests in the FAT's, CTP's, IOQ's & PQ's.
- Raise and follow to closure all deviations raised during the execution of FAT's, CTP's, IOQ's &PQ's
University degree in a related discipline preferred.
Relevant experience working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists