Website Ref: TPM04244
Our client is a global biopharmaceutical company based in Carlow looking for a Process Engineer who will be responsible for providing process, technical, and validation support operations including ongoing support of manufacturing processes and support for new product introduction.
- 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 revalidation.
- 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 e.g. FMEA, Fishbone diagrams, Implement subsequent corrective action through the change management system.
- Serve as technical engineering representative for internal technical group discussions and represent our client 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 our client’s 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 on site.
Qualifications & 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.
To apply for this job email your details to firstname.lastname@example.org.