Job Description

An amazing opportunity has arisen for a Process Engineering Specialist within our R&D facility at our new state of the art facility in Dunboyne. As a member of the Process Engineering group, you will be responsible for the evaluation and implementation of novel equipment, innovative processes, and the implementation of next generation technologies to keep us at the forefront of innovation in development and manufacturing of biologics.

Our R&D facility at Dunboyne, will be 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 Facility will provide Biologics Drug Substance manufacturing for Clinical Supply, Registration & Commercial Launch.

Our Dunboyne facilities serves as a magnetic force that attracts, recognizes, and integrates people of diverse backgrounds and perspectives. Employees will feel not only that they belong in the Dunboyne, but that the facility belongs to and is shaped by them.  

What you will do:

Bring energy, knowledge, innovation and leadership to carry out the following:

Participate in the planning, coordination, and implementation of next generation technologies being implemented in Batch and Continuous ManufacturingTransfer of platform technologies from the earlier pipeline facilities and bringing to GMP status locally.Transfer of platform technologies to future commercial facilities.Partner within a cross-functional team to implement new technologies / software / instruments that can simplify and reduce effort around manufacturing and administrative processes, sharing with network counterparts.Support the development of GMP Documentation such as:  Risk Assessments, Batch Records, Sampling Plans, Qualification Documents, and SOPs.Support troubleshooting and act as SME for manufacturing technology.Aggregate process related knowledge and centralize for knowledge management. Maintain GMP status of responsible equipment and areas by conducing routine monitoring, calibration, maintenance, certifications as needed.Support the area's implementation of process changes, and root cause investigation of deviations.Support Weekend or On Call duty on select time frames to support manufacturing during new technology introduction.Own life cycle development and qualification from initiation through implementation of methods / recipes for automated equipment, integrating into the overall site DeltaV System.Active member of a cross-functional team managing both process and automation aspects of responsible unit operations.Embody Safe by Choice – know and follow the Safety, Health and Environment guidelines and work towards company safety and environment goals.

What skills you will need:

In order to excel in this role, you will more than likely have:

Bachelor’s degree in biology, Automation, Medical Device Technologies, or Engineering.4+ years of experience in Biotech Industry (bulk manufacturing of pharmaceutical or biological components)Familiarity with processes for mAb manufacturing (bioreactors, chromatography, purification, filtration, concentration).Experience leading or supporting manufacturing process or equipment root cause investigations, specifically deviation management.Experience leading or supporting manufacturing process or equipment change controls.Competent in analyzing complex situations and show practical problem-solving capabilities.Verbal or spoken communication skills in English.Ability to work independently and within a cross-functional team.

The ideal candidate will also have:

Experience in upstream cell culture and bioreactor operations and technology a plus.Experience in Emerson DeltaV operation and recipe design a plus.Experience in Technology Transfer (new product introduction) a plus.Experience in Single-Use Component design a plus.

As a company, we are committed to 'Inventing for Life' in all that we do. 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.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

So, if you are ready to:
Invent solutions to meet unmet healthcare needs, please apply today.

Current Employees apply HERE

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:

Remote

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

03/5/2025

*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:R333516