Job title:
Process Engineer Contract
Company
RT Lane Recruitment
Job description
Process Engineer – Carlow – ContractExcellent Carlow based role – this position will suit someone with at least 3 years experienec ideally with Pharmaceutical GMP experienec supporting Operations.The new team member will serve as technical support for new product introduction (NPI) and commercial manufacturing.Role Functions * Lead/execute production floor-based activities
- Participate on a team of engineers
- Plan and execute validation activities as required
- Design & develop engineering studies
- 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
- Statistical data analysis to support development and commercialisation batches
- 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.
- 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
Experience, Knowledge & Skills
- Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other technical discipline
- Prior related work experience; ideally in manufacturing, preferably GMP Setting
- Typically have 3 years related work experience in Aseptic manufacturing / process engineering
- Knowledge of regulatory/core 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,
Qualifications & EducationBachelor’s Degree or higher preferred; ideally in a Science, Engineering or other technical discipline
Expected salary
Location
Carlow
Job date
Sat, 15 Mar 2025 23:30:42 GMT
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