- 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.
- 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
- Contribution to Kaizen events as appropriate.
- Serve as technical engineering representative for internal technical group discussions and represent the site 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 site Global Policies, Procedures and Guidelines, regulatory requirements and execute 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 site.
- May be required to perform other duties as assigned.
Qualifications & Education
- Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
- 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
- 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 contact Martin Lynch on 087-344 3581.
Email CVs to email@example.com