Equipment Commissioning Expert

6 days ago

Waterford, Waterford, Ireland beBeeValidation Full time €60,000 - €80,000
Process Validation Specialist
Our client is a biopharmaceutical company in need of an experienced Process Validation Specialist to support a new project. The role is crucial in ensuring ongoing validation and compliance of new equipment, systems, and processes.

Key Responsibilities:- Executing FAT/SAT/IOQ protocols including generation of protocols and reports.- Designing, executing, and reporting on validation studies for equipment, systems, and processes.- Ensuring validation studies are managed in conjunction with all required standards and legal requirements (Health & Safety, cGMP, construction, environmental etc.).- Providing technical interpretation and guidance of current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation, and dehydrogenation.- Ensuring that the validation status of equipment and systems are in compliance with cGMP at all times.- Maintaining validation documentation through the validation lifecycle.- Participation in external regulatory inspections.- Support Site Change Control process.

Required Skills and Qualifications:- Degree in Science (Chemistry, Microbiology, or Pharmacy preferred) or Engineering (Chemical, Mechanical, Electrical).- Experience: 3-5 years' experience working in a Healthcare manufacturing environment – ideally part of which would be in the pharmaceutical sector.- Sees projects/tasks through to completion.- Capable of troubleshooting validation issues associated with projects, process development, etc.- Competent technical knowledge of pharmaceutical plants.- Previous validation/product development experience would be highly advantageous for the role.- Knowledge of Process Validation regulations, current process validation and technical transfer industry practices, and experience of interpretation and application of guidelines and regulations.- Knowledge of requirements for GAMP, ISPE Baseline guides.- Knowledge of steam and dry heat validation publications such as AAMI/ANSI, PDA, and ISO guidelines.- Full understanding of relevant quality and compliance regulations.- Able to execute projects to plan.- Ability to use MS Project and SPC packages an advantage.- Understands KPI's for the site.

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