Process Engineer - Dun Laoghaire, Dublin
Alex Tosney 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.
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: Process Engineer Key Responsibilities include:
- Leads Packaging NPI activities from a Process Development perspective and serves as the Process Development Packaging SME.
- Acts as a combination product technical expert to provide solutions when troubleshooting Final Product Technologies (FPT) issues through the NPI or post-NPI phases.
- Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing.
- Troubleshoots issues with packaging equipment and associated vision systems.
- Conducts risk assessment for packaging operations and propose / implement appropriate CAPA.
- Identifies and implements operational opportunities for current and new packaging operations.
- Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management.
- Development of Characterisation Plans, IOQs and PQs
- Ensuring all aspects of activity within any given Design Transfer adheres to required policies and procedures, including safety and training.
- Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards
- Participate in Qualification Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.
- Pre-approve and post-approve process characterisation/qualification/validation protocols and assessments from a quality system documentation perspective.
- Knowledge of cGMPs and other worldwide regulatory requirements.
- Excellent written and verbal communication skills together with demonstrated ability to work in a team environment
- Proven track record of problem solving as well as leading and executing cross-functional projects
- Experience in support of Commercial Finished Drug Product (FDP) processing in specific areas such as Process Characterization, Tech Transfer (to commercial FDP sites) or Validation.
- Strong skills in applying fundamental engineering and scientific principles to the design and implementation of combination product/final pack processes
- Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
- Strong knowledge of Quality systems, Drug Product Packaging and Validation.
For more information or to apply for this position, please contact Alex Tosney on 01246 457 718 or email email@example.com. 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 KA44112 in all correspondence.