- Entry level
- No Education
- Salary to negotiate
- County Carlow
CK Group are recruiting for a Process Engineer to join a company in the Pharmaceutical industry at their site based in Carlow, Ireland on a contract basis for 12 months.
Our client has a long history of pushing the boundaries of science in order to help fight some the worlds most urgent global health challenges. This role is based at a state of the art biologics operation where they formulate and fill vaccines and biologic products.
The role is based at our client's site in Carlow, Ireland. Carlow is a fascinating town which pre dates written Irish history, has played a major part in Irish history and even served as the capital of the country in the 14th century.
- Serve as technical support for manufacturing and new product introduction.
- Design/Author/Review/Approve/Execute process development studies in support of new product introduction and ongoing manufacturing support.
- Provide technical input into quality notification by authoring/reviewing/approving investigations.
- Execution of equipment/qualification validation programs; including re-qualification and re-validation.
- Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process.
- Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
- Support continuous improvement through Lean Six Sigma methodologies.
- Leading and active participation in projects, system failure investigations and investigation reports.
- Execution/development of change controls.
- Contribution to Kaizen events as appropriate.
- Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues eg FMEA, Fishbone diagrams, 5 why's etc.
- Implement subsequent corrective action through the change management system.
- Serve as technical engineering representative for internal technical group discussions and represent technical Operations Carlow at global technical forums.
- Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
- Drive compliance of Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
- Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
- Work collaboratively to drive a safe and compliant culture in Carlow.
- May be required to perform other duties as assigned.
- Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
- Extensive GMP manufacturing experience required.
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 46811 in all correspondence