Project Engineer

Role Purpose:

• An exciting opportunity has arisen for a Project / Process Engineer to join our client’s busy pharmaceutical site based in Co. Cork.
• The successful candidate will plan, design, coordinate, validate and implement high technology equipment and/or processes for the site.
• They will also provide engineering support to ensure high yields and minimize downtime of process equipment prior to implementation into production.
• Reporting to the Engineering Manager.

Core Duties and Responsibilities:

• Responsible for introducing and validating new equipment and/or complex new process projects from design through completion and in compliance with regulatory requirements.
• Project management & planning and liaising with other departments affected by these projects. Also reporting project status to management and highlighting areas of concern early.
• Ensuring all projects are completed to agreed timelines and within budget.
• Planning and managing equipment implementation to ensure effective utilization of multi departmental resources both internal and external to the company.
• Assigned work adheres to EHSE requirements.
• Ensure continual Quality System compliance by adherence to established Client requirements
• Author and/or review and approval of protocols, technical reports, SOPs, and technical specifications.
• Compilation of technical documentation for regulatory submissions.
• Applying cost improvement and LEAN Manufacturing initiatives in projects.
• Responsible for optimising new processes through process analysis and the application of engineering principles.
• Manages assignments / project works performed by outside vendors.
• Provide Support to the engineering department when required.

Education & Qualifications Required:

• At least 5 – 6 years engineering experience in API Pharmaceutical industry in a production environment with Knowledge of process engineering, equipment, automation specification and GMP validation requirements.
• Bachelor’s degree in Process; Chemical; Mechanical Engineering or other related discipline.
• Project Management Qualification desirable
• Experience of current cGMP requirement of an FDA/HPRA approved facility.
• PC and software proficiency – Microsoft software and Microsoft project.
• Must be good record keeper and data analyser, attention to detail, accuracy and documentation skills
• Must be a self-starter who can work independently with minimal supervision.
• Strong team player with the ability to work collaboratively and cross functionally.
• A positive mindset of Safety First
• Travel may be required as part of the role from time to time depending on project needs.

Please note, we do not require agency assistance with this role.