Job Title:
Process Systems Validation Engineer
About the Role:
We are seeking a highly skilled Process Systems Validation Engineer to join our team for an 11-month contract at our Grange Castle site.
The successful candidate will provide technical expertise to ensure that systems and equipment are installed, commissioned, and qualified to regulatory specifications.
* Develop and implement documentation for commissioning/qualification of systems and equipment, including protocols and reports.
* Raise and implement system change controls and engineering change management procedures.
* Participate in design review for new or modified utility systems.
* Participate in construction system mechanical completion walkdowns.
* Execute commissioning protocols in field.
* Perform temperature mapping of equipment using Lives XpertVal system.
* Verify pre and post study calibration verifications.
* Operate according to standard operating procedures developed for validation, manufacturing operations, and compliance.
* Develop and implement changes required to resolve deviations effectively.
Requirements:
* B.Sc./B.Eng. degree in engineering discipline, with particular emphasis on mechanical or process engineering.
* Minimum of 3-5 years experience from biotechnology or pharmaceutical GMP manufacturing environment.
* Experience in temperature mapping is an advantage.
* Experience with qualification of clean utilities or HVAC is an advantage.
* Demonstrated ability to work independently and respond proactively to business needs.
* Excellent interpersonal and communication skills.
* Good documentation practice.
* Ability to read and verify P&IDs.