NPI Project Engineer - Dun Laoghaire, Ireland
CK group is recruiting for a NPI Project Engineer to join a company in the Biotechnology industry at their site based in Dun Laoghaire on an initial 12 month contract basis.
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.
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 NPI Project Engineer operates as part of a process team. This role will require the candidate to provide short term process development support to new product introduction (NPI) changes. The candidate will exclusively be involved in the execution of process performance qualification (PPQ) specifically documentation oversight and contribution to filings required for regulatory submission.
- At least a Third level Bachelor's degree in science, engineering Associate's degree or extensive experience in a similar role
- Knowledge of cGMPs and other worldwide regulatory requirements.
- Problem solving ability and excellent oral and written communications skills.
- Experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as sterile processing, process characterization, tech transfer (to commercial DP sites) or validation.
- Strong skills in applying fundamental engineering and scientific principles to the implementation and process validation of protein freeze-thawing, filtration, mixing, filling (PpK / batch homogeneity) and/or lyophilisation processes. Knowledge of protein biochemistry with regard to chemical and physical stability.
- Knowledge of Quality systems, Drug Product Manufacturing and Validation.
For more information or to apply for this NPI Project Engineer position, please contact Jenni on 01438 768 710 or email firstname.lastname@example.org. 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 KA42458 in all correspondence.