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Process Engineer

2 weeks ago

Carlow, Ireland PE Global Full time

PE Global is currently recruiting for a Process Engineer for a leading multi-national Biologics client based in Carlow.

This is an initial 11-month contract position.

Responsibilities

Serve as a technical and operations representative for established manufacturing processes and new product introduction. Collaborate within cross-functional teams and partner with colleagues to perform vendor management, communications, training, project work, audit/inspection duties, and ensure department readiness for audits/inspections. Design, author, review, approve, and execute process updates in support of ongoing manufacturing support and new product introduction. Provide technical input into quality notifications by authoring, reviewing, and approving investigations. Drive continuous process improvements using Lean Principles to optimize equipment uptime and target outputs. Oversee operations processes to ensure continuous, reliable, and repeatable manufacturing. Drive effective writing, revising, and rolling out of accurate operational procedures, training materials, and manufacturing procedures. Ensure process reliability and performance by facilitating effective systems for identifying root cause failures, making recommendations, and implementing improvement changes throughout processes. Drive continuous improvement by leading and actively participating in system failure investigations, investigation reports, change control execution/development, and Kaizen events. Support equipment commissioning and qualification programs representing operations. Review and approve qualification/validation documentation and studies. Perform data analysis and make informed decisions/recommendations based on the analysis. Support continuous improvement through Lean Six Sigma methodologies. Lead and actively participate in projects, system failure investigations, investigation reports, and change controls. Perform root cause analysis using standard tools and methods to resolve machine and system issues. Serve as a technical process representative for internal technical and operations group discussions and represent the company at global technical forums. Participate and/or lead cross-functional or single function teams, including liaising with vendors or above site groups. Drive compliance with company policies, procedures, and guidelines, regulatory requirements, and current Good Manufacturing Practices (cGMP). Ensure compliance through documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections, and proactive highlighting of compliance issues.

Requirements

Bachelor’s Degree or equivalent, ideally in a Science, Engineering or other Technical discipline Proven track record and established experience in a process engineer role with measurable accomplishments and achievements. 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.

Interested candidates should submit an