Job Description

An amazing opportunity has arisen for an Operations Production Associate Specialist within our R&D facility at our new state of the art facility in Dunboyne.

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:

Drug Support Process Operations point of contact for COMET.Monitor the SAP system to ensure optimal performance and proactively identify potential issues.Collaborate with Super Users for business support and closure of COMET/MES errors. Collaborate with the Global and local teams to implement system enhancements and upgrades and take part in global CoP.Provide support to the Manufacturing team to resolve any issues in a timely manner.Training and Compliance: Provide training and support to production personnel on SAP and others systems functionalities, production processes, and compliance with standard operating procedures, health and safety protocols.Collaborate with SAP/GLIMs superusers and support with builds/upgrades coming from NPI.Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop support weekend or on-call duty on select time frames to support manufacturing.

What education, experience and skills you will need:

In order to excel in this role, you will need:

3 years + experience in Biotech Industry (bulk manufacturing of pharmaceutical or biological components). Position level will scale with experience level of candidate Proficient in SAP modules such as Production Execution (PE), Material Handling (MH), and Materials Management (MM) to effectively manage production processes within the pharmaceutical industry.Experience working in a GMP/regulated environment with an Understanding of Upstream and Downstream Unit Operations for mAb manufacturing.Analytical and Problem-solving Skills: Ability to analyse complex production data, identify process gaps, and propose effective solutions to streamline operations and enhance productivity.Communication and Teamwork: Excellent communication skills to liaise with cross-functional teams -Experience in resolving production-related issues, and foster collaboration across different departments.Proficient in SAP COMETOrganisation Skills – Ability to manage multiple priorities and know when to escalate issues for resolution.Knowledge of GLIMs desirable Problem, Deviation, and Change Management experience.

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:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

02/14/2025

*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:R332006