Purpose:

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.

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 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 lifecyc/e
Participation in external regulatory inspections
Support Site Change Control process

Requirements:

Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering Chemical/Mech/Elec
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 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, ISP£ Baseline guides.
Knowledge of steam and dry heat validation publications such as MMI/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 KPl’s for the site.