Validation Engineer

12 month Validation Engineering contract available in pharmaceutical manufacturer in south-east Ireland

The Opportunity:

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.

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 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 company 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.

Soft skills:

·      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.

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 American National Standards, 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)

Languages: English

For more information on this position please contact Jenny Navan via phone or email in Cpl

Cpl are an equal opportunities employer.

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