Process Plant CQV Engineer

3 weeks ago

Waterford, Waterford, Ireland Tandem Project Management Limited Full time

Summary: Our client is a biopharmaceutical company in Waterford looking for a Validation Engineer to to support a new project. The Validation Engineer has a key role in ensuring the on-going validation and compliance of new equipment, systems and processes. 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 Sanofi 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 Qualifications & Experience: Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering Chemical/Mech/Elec). 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 of 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 KPIs for the site.

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