R.T. Lane Recruitment are currently recruiting for a Process Engineer – Tech Transfer/NPI to work with a Pharmaceutical Company in Carlow.
This is an Initial 11-month contract with strong potential for extension. Hybrid option available for this position.
Please note that candidates must hold the correct working visa for Ireland as my client cannot offer visa assistance and must be already residing in Ireland.
Brief outline of Role:
New opportunity now exists for a Process Engineer to join the Process Engineering Group on site and report to the Technical Engineering Manager.
You will serve as technical support for new product introduction (NPI) and commercial manufacturing and will participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
You will typically have prior related work experience; ideally in manufacturing, preferably in a GMP setting.
Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial but not a necessity for this role.
Role Functions:
* Design/Author/Review/Approve/Execute qualification/validation documentation and process development studies in line with the standard approval process.
* Design/Author/Review/Approve/Execute Execution/development of change controls.
* Contribution to Kaizen events as appropriate.
* Technical input into quality notification by authoring/reviewing/approving investigations.
* Support continuous improvement through Lean Six Sigma methodologies.
* Perform root cause analysis of system failures and substandard performance using standard tools and methods to resolve machine and system issues.
Essential Requirements:
* Bachelor’s Degree or higher preferred in a Science, Engineering, or other technical discipline.
* Minimum 3 years’ experience ideally in manufacturing, preferably in a GMP setting.
* Demonstrable experience of leading technical-related projects.
* Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices.
* Report, standards, and policy writing skills required.
* Equipment and process validation experience.
* Sterile filling processes and equipment knowledge.
* Proficiency in Microsoft Office and job-related computer applications required.
* Excellent communication, presentation, and interpersonal skills to interface effectively with all levels of colleagues and with external customers in a team-oriented manner.
For more information or a full Job Description please contact Michelle Power, R.T. Lane Recruitment on 022 46969, 087 032 8195 or email michelle@rtlanerecruitment.ie.
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