CSV Engineer - Dublin
CK Group is recruiting for a CSV Engineer to join a company in the Pharmaceutical industry at their site based in Dun Laoghaire on a 6 month contract basis.
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.
- Computer Systems Validation, Quality Management, Quality Assurance.
- Infrastructure Quality Management.
- Project Quality Management.
- Compliance Assessment, FMEA, Risk Assessment including GxP Training and Coaching of CSV activities and periodic reviews for SOPs, review documentation.
- You will have some experience in GxP Applications CSV (Protocol and SOP writing experience is essential).
- To succeed in this role you will have extensive knowledge of Computerised System Validation within a cGMP and HP ALM review and approval of testing. Creation of plans/protocols and reports.
- Knowledge of GxP, 21 CFR Part 11 and other industry relevant.
For more information or to apply for this position, please contact Julie on 01438 723500 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45778 in all correspondence.