Validation Engineer

Summary:                      

Our client, a biopharmaceutical company based in Cork, is seeking a Validation Engineer to support validation activities in a GxP regulated environment. The successful candidate will work within the Commissioning, Qualification and Validation (CQV) function and will be responsible for supporting the implementation of laboratory systems, new manufacturing equipment/processes, and changes to existing equipment/processes.

Responsibilities:

• In collaboration with plant support functions, assist with planning, set up and implementation of Analytical Instrument Qualification, Facilities, Utilities, Equipment (FUE) Qualification and Process Validation programmes
• Execute validation activities (protocol generation, execution, and final package preparation) across various validation disciplines, including FUE Qualification, CSV, New Product Introductions and Change Control
• Develop validation plans for specific system implementation projects
• Support the establishment of site validation policies through development, generation and implementation of site validation master plans, guideline documents and standard operating procedures
• Prepare and track to completion any assigned change requests, deviations, quality events and associated CAPAs
• Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance
• Assist with preparation of regulatory filings and participation during regulatory inspections and partner audits
• Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured on site, validation techniques/approaches and systems utilised
• Lead and represent validation in multi-departmental meetings and project teams
• Identify and implement improvements to Engineering Validation systems
• Coordinate validation activities involving cross-functional, multi-departmental teams including Manufacturing, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others
• Other duties as assigned

Qualifications & Experience:

• Degree in Engineering, Science or a related discipline
• Experience working in a GxP regulated environment (biopharma, pharma, medical devices or similar)
• Hands-on experience supporting validation activities, including equipment qualification and/or process validation
• Experience generating and executing validation protocols and compiling final validation packages
• Working knowledge of change control, deviations, quality events and CAPA processes