Process Equipment Engineer

1. General Information:

Job Title: Drug Substance 2 Process Equipment Engineer

Department: DS2 Project – Engineering

Position Reports to: DS2 Project – Engineering Lead

2. Job Purpose:

The role will be DS2 Process Engineer and will involve:

• Providing Process, Equipment, Automation engineering and technology support to the DS2 Operational Unit (OpU). The process equipment engineer is responsible for providing Equipment/Automation qualification support to DS2 during start-up and ensuring that the Equipment/Automation is running as intended and that all equipment issues are resolved to support the manufacture and timely disposition of product. Becoming a Process/Equipment SME for the introduction of new products into the OpU.
• This role focuses on resolving technical and engineering issues, implementation of CAPAs and process/equipment improvements, providing routine technical support and troubleshooting, investigation closeout and maintaining the qualification status of the physical plant and equipment.
• The process equipment engineer will be involved in the execution of projects, which may include the coordination of internal company resources and vendors as part of the execution of projects. The process equipment engineer is responsible for providing technical expertise during audits and also to present/defend engineering systems, applicable change controls, investigations and equipment qualification packages to the regulatory agencies as required.
• Working with a team of welcoming and supportive project colleagues in Engineering, Technical Services, Operations, Technical Operations, Quality, Utilities as well as sustaining colleagues from the existing Operations Units in Grange Castle.
• This is an opportunity to join a world class facility which is dedicated to bringing therapies that will significantly improve patients’ lives.

3. Responsibilities:

The Process Equipment Engineer will report tothe DS2 Engineering Managerand within the role will be required to:

• Ensure all installed DS2 equipment is safe, effective and in compliance with industry standards and process requirements.
• Gain understanding of the new DS2 Delta V Automation and how the equipment runs. Learn the Delta V Historian trending capabilities and interaction with the PI trending software with an aim to troubleshooting Batch deviations. Gain access to both Delta V Target and Development systems to be able to monitor real-time Batch manufacture and troubleshoot issues by simulating manufacturing scenarios.
• Understanding of the CIP/SIP circuits across Upstream/Downstream.
• Assist in the shakedown and commissioning of new equipment during C&Q. Provide technical and compliance review of C&Q testing protocols and reports.
• Support Technical/Engineering Operations in the development of Engineering Work Instructions/SOPs/LOTO procedures/spares for the safe maintenance of the new equipment.
• Gain an understanding of our site SOPs and amend where necessary for the DS2 building.
• Support equipment related investigations and implement equipment CAPA and performance improvements.
• Support small to medium sized capital projects within DS2.
• Generate and execute documentation for cGMP validation, equipment & manufacturing processes, including validation plans, risk assessments, IQ/OQ/PQ/CQV/C&Q protocols and reportsfor the qualification ofnew equipment.
• Write structured Engineering memos in support of investigation closures. Partake in Method 1’s to determine root cause and implement corrective actions.
• Provide routine equipment technical support and troubleshooting for resolution of manufacturing issues.
• Provide technical training on process and equipment as required by Operations/Technical Operations.
• Develop and maintain productive links with process equipment & technology suppliers and vendors.
• Support Compliance Inspections and enquiries from Regulatory Agencies.
• Provide technical expertise during audits and also to present/defend engineering systems, applicable change controls, investigations and equipment requalification packages to the regulatory agencies as required.
• Represent Engineering on project teams where responsibilities would include 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.
• Work to implement a culture of Right-First Time through partnerships with Operations, New Product Introduction teams and Technical Services.

4. Education/Experience:

To be successful in this role you willrequire:

• Minimum qualification of a Degree in Engineering with particular emphasis on Process and Chemical disciplines or equivalent.
• Minimum 2 years’ Engineering/Technical experience in a biopharmaceutical/pharmaceutical/medical devices cGMP manufacturing environment.
• Understanding of biopharmaceutical process equipment including but not limited to: Vendor Packaged Equipment, Process Vessels, Bioreactors, Chromatography, TFF (Perfusion, UF/DF), Autoclaves, CIP, and Parts Washers.
• Experience in troubleshooting Equipment/Automation issues during commissioning/qualification/start-up/manufacturing.
• Hands-on experience with DeltaV MCS or other DCS/PLC Automation system is desirable.
• Understanding of Change Control processes.
• Experience working in a cleanroom manufacturing environment.
• Understanding of technical aspects of equipment installation, start-up, troubleshooting and repair or to obtain appropriate outside repair services to accomplish same.
• Experience with use of Lean Tools such as Standard Work/5S and Six Sigma techniques such as Method 1 and 5-Whys is desirable.
• Excellent people skills, positive influence, team orientation, diligence, documentation, problem identification and critical thinking skills.
• An ability to work independently and as a member of a self-managed team in a dynamic, challenging environment that requires flexibility and initiative.

Work Location Assignment

Pfizer Grange Castle: Predominantly on-site(Flexible)

Monday to Friday Day based role 

Application Closing date: 4th Nov 2025 00:00hours

All applicants must have relevant authorisation to live and work in Ireland.

Engineering