Process Engineer
Asset Recruitment is recruiting a Process Engineer for a contract role, on behalf of our client, a growing pharmaceutical manufacturer in Carlow. Reporting to the Technical Engineering Manager, the successful candidate will be responsible for providing 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.
This is initially an on-site role, with a hybrid arrangement available after successful completion of training. Occasional shift support may be required based on program needs.
Responsibilities include but are not limited to:
* Design/Author/Review/Approve/Execute qualification/validation documentation and process development studies in line with the standard approval process
* Design/Author/Review/Approve/Execution/development of change controls
* Technical input into quality notification by authoring/reviewing/approving investigations
* Execution of equipment/qualification validation programs; including re-qualification and re-validation
* Contribution to Kaizen events as appropriate
* Assist continuous improvement through Lean Six Sigma methodologies
* Execute root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues
* Act as technical engineering representative for internal technical group discussions and represent technical Operations Carlow at global technical forums
Requirements:
* Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
* 3+ years’ experience ideally in manufacturing, preferably GMP Setting
* Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable but not a necessity
* Demonstrable experience of leading technical related projects
* Experience in equipment and process validation
* Sterile filling processes and equipment work experience
* Proficiency in Microsoft Office and job-related computer applications required
* Excellent communication, presentation, and interpersonal skills.
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