Validation Engineer

Validation Engineer

 You will be required to support new product introductions, equipment

qualification and the site requalification program. The Validation Engineer has a key role in ensuring the on-going validation and compliance of existing and new equipment, systems and processes at Sanofi Ireland. The following activities will be included as part of your role.

Main responsibilities:

Designing, executing and reporting on PV/Process Performance Qualifications.

·       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 depyrogenation

·       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

About you

Experience: 3-5 years’ experience working in a Healthcare manufacturing

environment – ideally part of which would be in the pharmaceutical sector.

Technical skills:

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.

·       Good knowledge of quality management systems.

·       Good communication skills at organisation, team and individual levels.

·       Ability to use MS Project and SPC packages an advantage

·       Understands KPI’s for the site.

Education:

Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering Chemical/Mech/Elec)