21925 – Process Engineer – Tech Transfer – NPI – Carlow Contractor

Purpose

This role 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. Typically have prior related work experience; ideally in manufacturing, preferably GMP Setting but we will consider applicants from other working environments as long as they have technology transfer experience.

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 for this role.

Our Engineers support internal and external manufacturing operations remain operational, continuously improve, and innovate.

Responsibilities

• 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.
• Execution of equipment/qualification validation programs; including re-qualification and re-validation.
• Support continuous improvement through Lean Six Sigma methodologies.
• Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.
• Serve as technical engineering representative for internal technical group discussions and represent technical Operations at global technical forums.
• Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made. Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
• Work collaboratively to drive a safe and compliant culture.
• May be required to perform other duties as assigned. Contribute for driving a culture of Continuous Improvement by deploying MPS within the IPT on projects such as: problem solving, reducing cycle time, Lean principles within the new processes.
• Stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels
• Participate and comply with the company Quality Management System (QMS) requirements, including ownership, as relevant.

Requirements

• Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
• Min 3 years’ experience ideally in manufacturing, preferably GMP Setting.
• Demonstratable experience of leading technical related projects.
• Evidence of continuous professional development is desirable.
• 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.
• Knowledge of regulatory/code 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.
• Excellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.