Job Description

An amazing opportunity has arisen for an Operations Specialist, within the Technology Transfer Delivery Team, at our new state of the art, single use, multi-product facility in Dunboyne.

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

The Technology Transfer Delivery group will work closely with external stakeholders as well as internal partners such as Process Engineering, Quality, Operations, Process Automation and Development to deliver seamless NPI to our multi-product facility.

The successful candidate would be a responsible for supporting New Product Introduction, while also acting as a key contributor to the evolving site tech transfer strategy. They will also act as a Change Champion within the organization and site, to bring about new products, digitization, and ways of working 

What you will do:

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

Collaborate with stakeholders to execute the transfer requirements of both late stage clinical and/or PPQ (Process Performance Qualification) programs.Attend meetings with local and international groups to coordinate and execute implementation tasks for new Drug Substance processes.Manage new program introduction schedule to ensure tasks are executed on schedule and right-first-time. Collaborate with stakeholders to deliver GMP documents related to TT, such as Risk assessments, change controls, batch records, sampling plans, Bills of Material. Support development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes Employ innovative and continuous improvement mindset to identify and implement opportunities to enable product launch.Ensure the highest Quality, Compliance and Safety standards and embody Safe by Choice – know and follow the Safety, Health and Environment guidelines and work towards company safety and environmental goals Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.Excellent trouble shooting and problem-solving skills as well as influencing, collaboration skills and teamworking ability to work with global and interdisciplinary teams.

What skills you will need:

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

Minimum of 3 years of work experience in the pharmaceutical or biotech industry  Bachelor’s degree in Engineering, Biotechnology, Chemistry, or related field.Technical knowledge with Biologics drug substance upstream and downstream operations or process development.Understanding of the principles and activities of New Product Introduction NPI/Tech TransferFamiliarity with the use of Automation systems in a manufacturing Process such as DeltaV, MES, eVal as well as business tools such as Power Project and Power BI.Demonstrated experience in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems. Validation experience including validation documentation generation and executionCompetent in analyzing complex situations and showing practical problem-solving capabilities  Ability to work as part of a team and on own initiative in a constructive manner.

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. 

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.

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:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

03/14/2025

*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:R329060