CK Group are recruiting for a CSV Engineer to join a company in the Pharmaceutical industry at their site based in Dun Laoghaire on a 12 month contract basis. Hourly rate for LTD contractors is €44.16.
The Company: Our client is one of the worlds leading manufacturers of biosimilar and biopharmaceutical products used in the treatment of a wide range of human healthcare conditions from cancer to arthritis. This company are a strong believer in helping patients by developing new treatments and taking them to market via their global network of specialist aseptic manufacturing, packaging and distribution sites.
The Location: This role is located on a state of the art manufacturing facility based in Dun Laoghaire and is a quick 30 minute drive away from the centre of Dublin, or 60 minutes drive from Dublin Airport. The site is easily commutable from Kildare or Wicklow by car and there is a good public transport network if you would prefer to live within Dublin itself. Dun Laoghaire is a vibrant cultural hub in south Dublin which is best known for its maritime history and locally caught sea food.
- Development of Validation Plans, Installation Qualifications (IQs), Operational Qualifications (OQs) and Summary Reports.
- Review and Approve validation protocols and assessments from a quality system documentation perspective.
- Prepare, execute, document and report validation protocols in line with GMP's and other regulatory requirements and standards.· Participate and communicate as required in project activities.
- Candidates must have at least 5 years' experience in GMP Regulated Environment.
- Computer system validation lifecycle is essential.
- Working knowledge of GAMP software development lifecycle.
- Bachelor of Science/Engineering degree or equivalent.
Entitlement to work in the EEA is essential. For more information please contact Natasha on 01438 723500 or email email@example.com. Please quote reference 47768 in all correspondence.