High Salary Process Plant CQV Engineer

3 days ago

Waterford, Waterford, Ireland Tandem Project Management Ltd. Full time
Overview

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 KPI's for the site.

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