Validation Engineer

Validation Engineer

A leading Biotech company based in Waterford is seeking a Validation engineer to add to their team on a 12month contract. This is a Hybrid role but successful applicant must be flexible to come to site when required.

Our Team:

In the Validation Engineer role, 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:

The following activities will be included as part of your role:

·       Designing, executing and reporting on PQ 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

·       3-5 years’ experience working in a Healthcare manufacturing environment – ideally part of which would be in the pharmaceutical sector.

·       Natural influencer and works well as part of a multifunctional team.

·       Highly motivated and self-resilient.

·       Adaptable and flexible as well as a pragmatically minded problem solver.

·       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 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)

For more information and a confidential chat, feel free to reach out to me on [email protected] or call me on 01-482 5494