CSV Engineer - Dun Laoghaire, Ireland
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 12 month contract basis with an hourly rate of €52.
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.
The Role: Development of Validation Plans, Installation Qualifications (IQs), Operational Qualifications (OQs)and Summary Reports.
Key Responsibilities include:
- Prepare, execute, document and report validation protocols in line with GMP's and other regulatory requirements and standards
- Assure that all validation test procedures are in line with current technology, corporate and governmental regulations
- Ensure that the Validation Strategy meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards
- Review and Approve validation protocols and assessments from a quality system documentation perspective
- Liaise with Engineering / Automation and external vendors regarding equipment documentation, HDS, SDS, FDS, User Requirement Specifications (URS's), and any other associated validation issues
- Participate and communicate as required in project activities
- Develop procedures to manage computerised systems where required
- Develop and present project plans to project management senior staff
Your Background: To succeed in this role you will have extensive knowledge of Computerised System Validation within a cGMP and working knowledge of GAMP software development lifecycle, ANSI/ISA-S88 industry standards.
For more information or to apply for the CSV Engineer position, please contact Natasha Young on 01246 457739 or firstname.lastname@example.org. Alternatively, please click on the link below to apply online now.
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 45276 in all correspondence.