Technical Engineer - Carlow, Ireland
Jenni at CK Group is recruiting for a Technical Engineer to join a company in the Pharmaceutical industry at their site based in Carlow on a 12 month contract basis.
The Company: 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 Location: 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.
The Role: Responsible for providing process, technical, and validation support operations including ongoing support of manufacturing processes and support for new product introduction. Accountable for analytical/engineering studies associated with the development of new components, products, processes systems and facilities. Co-ordination, design and execution of equipment qualification and validation as required.
- Serve as technical and/or validation support as required 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 commissioning and qualification programs.
- 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.
- Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. 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.
- Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
- Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
Your Background: To succeed in this role, you should have the following skills, knowledge and experience:
- Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
- Would typically have prior related work experience; ideally in manufacturing, preferably GMP Setting.
- Relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably in a GMP setting.
- Considerable experience in a comparable role: would typically have experience operating as a senior professional and adding considerable value to the business; in a GMP manufacturing setting.
- Demonstrated technical leadership and delivery of complex cross functional / cross site projects. SME in multiple aspects of aseptic processing.
- Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
- Report, standards, policy writing skills required.
- Equipment and process validation.
- Sterile filling processes and equipment.
- Proficiency in Microsoft Office and job related computer applications required.
- Lean Six Sigma Methodology experience desired.
- Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
For more information or to apply for this position, please contact Jenni on 01438 768 710 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 44635 in all correspondence.