HVAC Validation Engineer

Working for a Global Biotech organisation that currently requires an experienced HVAC Validation Engineer to work at their facility in Ireland (Dublin area).

The successful candidate will be working on a new exciting €200 million project, which primarily is for a new syringe filling line/packaging building (3 storey building) and required alterations to existing buildings to support this.

You will be responsible for:

Ensuring that the Validation Activities associated with the HVAC/Utilities for a Sterile Manufacturing Facility project are in compliance with System requirements and international standards.
Preparation of Validation Plans, Installation Verification, Functional Testing, Performance Qualifications (PQs) and associated summary reports for HVAC and Utilities for the Sterile Fill Finish Facility.
Ensure all aspects of HVAC/Clean Utility Validation adhere to required policies and procedures; including safety and training.
Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective for HVAC, Clean Steam, Process Air, Nitrogen, Purified Water and WFI Systems.
Pre-approve and post-approve Factory Acceptance Tests (FAT's), Site Acceptance Tests (SAT's), User Requirement Specifications (URS's), Quality Risk Assessments for Equipment and Automated Systems (QRAES), Commissioning Test Matrix's
Collate and report on relevant Validation data/matrices.
Assist in deviation and exception resolution and root cause analysis.
Participate in walkdowns of HVAC and Clean Utility systems
Preparation of Standard Operating Procedures
Participate in cross functional team meetings

Excellent opportunity to work for a company who provides an outstanding work environment and opportunities for career development.