Summary: Our client, a biopharmaceutical company based in Cork, is seeking a Validation Engineer to support validation activities in a Gx P 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 Gx P 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