Process Engineer Contract

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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