Job Description

An opportunity has arisen for Process/Project Engineer (Associate Director) to join the team at our newly constructed Biologics Innovation facility located in Dunboyne, County Meath. The facility is a premier, state-of-the-art facility that enables and advances our best work. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions.  The innovation facility will provide Biologics Drug Substance manufacturing for Clinical Supply, Registration & Commercial Launch.  

The facility is designed to be operated in a multi-product mode which requires flexibility to adjust as the pipeline of clinical and commercial biologics-based medicines demands change. A multi-product strategy for equipment design and implementation will enable the facility to adapt in a flexible and agile way for rapid product launch.

The Process/Project Engineer will be a member of the Enabling Technology and Engineering Leadership team, reporting to the Head of Enabling Technology and Engineering. The successful candidate will be a key stakeholder in the delivery of new technologies and for support on existing equipment.

Key responsibilities will include: 

Responsible for the successful execution of Engineering projects designed to deliver robust and optimized manufacturing processes, as well as the provision of day-to-day technical support and expertise to the operations teams.Apply a project management approach for successfully project delivery, from scope development, resource planning, stakeholder alignment, project execution and closeout.Lead process & project decisions based on risk and the interpretation of data sets ensuring consultation and communication with stakeholders.Lead the timely introduction of new processing technologies for routine full-scale manufacture, inclusive of validations ensuring a cost effective, compliant, and robust process is achieved.Provide technical support and expertise as required to achieve process optimisation. Identify and generate opportunities for improvement and actively participate in the implementation of corrective action plans and continuous improvement initiatives.Liaise closely with Process engineering, Tech transfer and Operation teams for project identification and lead cross functional.In partnership with Process Automation actively support Digital Transformation initiatives in a cGMP environment involving system integrations, data connectivity, and simplification.Conduct investigations; equipment and process related troubleshooting, and root cause analysis, implementing appropriate corrective and preventative actions where necessary.Support all departments, particularly Safety & Quality, and Operations in relation to Engineering changes.Demonstrate a high level of accountability and ownership for performance.Train, coach, and mentor colleagues on new technologies and/or manufacturing processes.Ensure highest Quality & Compliance standards, participating and complying with the Quality Management System and Quality Risk Management.Comply with all company policies and procedures, including quality requirements, financial controls, health, and safety regulations.Top of Form

Your profile

Engineering degree or equivalent with min 10 years’ experience.Demonstrated experience in a GMP-regulated large molecule drug substance manufacturing environment, ideally with experience of single-use systems.Proven experience in a leadership role managing projects in the biotech sector, from scope development through qualification, validation, and operation.Possess a deep technical understanding of a manufacturing/operational GMP (Good Manufacturing Practice) environment with detailed knowledge and experience of both upstream and downstream processing being a significant advantage.Delta V and MES (Manufacturing Execution System) knowledge and experience an advantage.Effective oral / written communication skills in English.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.

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Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

02/7/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R334202