As a HVAC/Utilities validation engineer, you are responsible for ensuring that the Validation Activities associated with the HVAC/Utilities for a Sterile Manufacturing Facility project are in compliance with Division Quality System requirements and recognised 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 meetingsJob Description
As a HVAC/Utilities validation engineer, you are responsible for ensuring that the Validation Activities associated with the HVAC/Utilities for a Sterile Manufacturing Facility project are in compliance with Division Quality System requirements and recognised 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
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical
