Jenni at CK Group is recruiting for a Process Engineer to join a company in the Pharmaceutical industry at their site based in Dun Laoghaire on a 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.
This role will require the candidate to provide process development support primarily to the Forensics and Defect Laboratory. The candidate will establish themselves as an expert in forensic identification of Drug Product defects and maintain and produce extensive defect panels used to support automated and manual visual inspection of vial (liquid / lyophilised) and syringe packaged drug products.
· Perform experiments, organise data and analyse results with minimal supervision to evaluate product impact due to process variables encountered during drug product manufacture.
· Creation, Management and Maintenance of Inspection defect panels / sets.
· Execution of Knapp studies and data analysis.
· Establish experimental design, develop and implement protocols, obtain reproducible and reliable results and communicate data to cross functional groups.
· Ensuring all aspects of laboratory activity adheres to required policies and procedures, including safety and training.
· Ensure that the laboratory and site meet the quality requirements of its customers and applicable regulations.
· Participate in cross functional teams at the site to ensure adherence to required policies and procedures and be responsible to deliver against organisational goals and project milestones.
· Assist in deviation and exception resolution and root cause analysis.
· Third level bachelor's degree in science, engineering or a relevant quality discipline with experience.
· Experience in Working in a Laboratory Environment.
· Knowledge of cGMPs and other worldwide regulatory requirements.
· Problem solving ability and excellent oral and written communications skills.
· Masters in Science or Engineering.
· Prior experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as sterile processing, process characterization, inspection, tech transfer (to commercial DP sites) or validation.
· Be familiar with advanced microscopy (scanning electron microscopy) and spectroscopy (Fourier-transform infrared spectroscopy).
· Understanding of degradation mechanisms for biologics, analytical methods, laboratory practices, and basic statistical methods.
· Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
· Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
· Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion.
The Process Engineer will work on the following shift pattern:
Shift A :Mon-Thur 2:30pm to 10:30pm and Fri 1:30pm to 8:30pm
Shift B: Mon-Thur 7am to 3pm and Friday 7am to 2pm
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 KA44394 in all correspondence.
You MUST be eligible to work in Munster. Learn more
- Agency: CK Group
- Contact: Jennifer Woolley
- Phone: 01438 743047
- Reference: KA44394
- Posted: 11th January 2019
- Expires: 8th February 2019