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  • CORK,
  • Job reference number:15424304
  • Client ID:RI/CW122342
  • Posted on:29-JAN-2019
  • Job type:PERMANENT

We urgently require Contract & Permanent Validation Engineer for an Innovative Pharmaceutical company. If you have experience in validating any of these Autoclaves, Sterile Filler, Depyrogenation Tunnels, Vial Wash, VHP Isolator and HEPA systems then this is the JOB for you.

* Leading and Managing projects for the validation equipment, processes and products to meet all safety, quality, regulatory and operational requirements.
* Leading cross functional teams as part of project planning and deployment including collaboration with Quality, Safety, Operations, Facilities and Engineering, Supply Chain and Regulatory Affairs
* Process mapping and gap analysis.
* Review of equipment specification/design/procurement/installation and validation.
* Project planning and execution including scheduling, task management, milestone planning and reporting.
* Generation, review and approval of project documentation (User Requirement Specifications, validation protocols, reports etc.) and Standard Operating Procedures.
* Support validation activities for project activities including review of validation documentation and attendance at validation activities (FAT, IQ ,OQ etc.),
* To approve plant SOPs and other documents as required, ensuring the acceptability of content and format.
* Maintain the Site Validation Master Plan (VMP) and associated Project VMP's, defining the validation approach associated with each piece of equipment, system, process and the requalification requirements including study requirements and frequency.
* Site audit facing validation SME

* 3-5 years' experience in a cGMP biopharmaceutical or aseptic filling environment.
* Must have direct experience performing equipment, utility, and/or computer system qualifications studies in a cGMP aseptic filling environment.
* Strong validation knowledge equipment of such as Autoclaves, Sterile Filler, Depyrogenation Tunnels, Vial Wash, VHP Isolator and HEPA systems.

Please call Louise Mulligan today for further information on 0949003979 or email:

CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the Medical Devices, Pharmaceuticals, 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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