Validation Engineer

A Validation Engineer is required on an initial 12-Month basis by CareerWise Recruitment for our Waterford-based Biopharmaceutical Client.

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 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 client 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

REQUIREMENTS:

3-5 years' experience working in a Healthcare manufacturing environment - ideally part of which would be in the pharmaceutical sector.
* Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering Chemical/Mech/Elec)
* 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 KPIs for the site.

Please call Aisling O'Hagan-Yil today for further information on 021- 2427410 or email: aohagan-yil@careerwise.ie

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

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