Process Engineer
This is an exciting opportunity to join a leading multi-national Biologics company in Carlow as a Process Engineer.
Key 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.