Process Engineer

Role Purpose:

• A fantastic opportunity has arisen for a Process Engineer at our client’s busy pharmaceutical site based in County Dublin.
• This role will be a hybrid position, it will be split between the client site in Dublin and the Kilkenny Design Office.
• The successful candidate will provide process and equipment engineering, and technology support to the project team for a new manufacturing site expansion project.
• The process engineer is responsible for providing engineering and equipment qualification support to the Commissioning and Qualification team ensuring that systems (process and equipment) are fit for use and validated as intended to support the release for manufacture of equipment and services.
• This role focuses on commissioning and qualification of systems, resolving technical and engineering issues and execution of commissioning and qualification activities. This includes generation and close out of qualification documentation.
• The process engineer is responsible for project management and / or execution of discrete scopes of work feeding into the overall project delivery.
• The process engineer is responsible for providing technical, operational, compliance and qualification support with respect to GMP and non GMP systems.
• The successful candidate will be expected to be flexible and agile in support of the project’s overall mission, interface with core engineering facilities, reliability, maintenance, calibration and automation functions as required.

Core Duties and Responsibilities:

• The Process Engineer will report to the Engineering Lead and should have the ability to:
• Ensure all systems installed are safe, effective and in compliance with industry standards.
• Ensure all company and site engineering policies and procedures are adhered to.
• Provide technical and compliance review of testing protocols and reports.
• Provide SME technical oversight and the management and resolution of technical issues or changes arising throughout the project lifecycle whilst ensuring overall project objectives of scope, cost and schedule are adhered to.
• Lead or support commissioning and qualification related investigations and implement CAPA and performance improvements.
• Generate and execute documentation for cGMP and non-GMP equipment qualification, risk assessments, IQ/OQ/PQ/QV protocols and reports to qualify new equipment.
• Work to implement a culture of Right-First Time through partnerships with Operations, New Product Introduction teams and Technical Services.

Education & Qualifications Required:

• Minimum qualification of a Degree in Engineering or Science with particular emphasis on Process, Chemical and Mechanical disciplines.
• Minimum of three years relevant experience in Engineering, Technical or Operations.
• Experience working in an Engineering or Technical discipline with exposure to one or more of the following:
  • Drug Product Aseptic processing
  • Bulk Drug Substance manufacture
  • Vaccine Conjugation
  • Small molecule API
  • Medical Devices
• GMP industrial experience, ideally covering Engineering, Projects and equipment qualification in a regulated environment.
• Understanding of Pharma process equipment including: Process Vessels, Chromatography, Ultrafiltration, Autoclaves, CIP systems, Parts washers, and Clean Utilities.
• Ability to direct technical aspects of equipment installation, start-up and troubleshooting.
• Demonstrated ability to provide technical solutions for complex problems through equipment and process understanding. Knowledge of structured problem-solving tools such as Process Mapping, RCA (Root cause analysis), FMEA’s (Failure Mode effects analysis) etc.
• Excellent communication and interpersonal skills and an ability to work independently
• Would be an advantage:
• Working operational knowledge of Emerson Delta V
• Familiarity with lock out tag out work safety methods
• Experience of operating with various control systems platforms, PLC, DCS, SCADA.
• Have worked in a Commissioning/Qualification/Validation role previously