Qualification Engineer

A Qualification  Engineer is required by CareerWise Recruitment for our Waterford  based Pharmaceutical client. You will be required to support the site requalification program. The Periodic Qualification Engineer has a key role in ensuring the on-going validation and compliance of existing and new equipment, systems and processes . This is a 12 month contracting position. This is a hybrid position with 3 days on site required for the position 

THE ROLE:

• Designing, executing and reporting on periodic qualification program.
• Designing, executing and reporting on periodic requalification studies for equipment, systems and processes.
• Ensuring periodic qualification 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.
• Participation in external regulatory inspections.
• Support Site Change Control process.
  
  

REQUIREMENTS:

• Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering Chemical/Mech/Elec)
• Experience: 3-5 years’ experience working in a Healthcare manufacturing environment – ideally part of which would be in the pharmaceutical sector.
• 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

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