Job Description

An opportunity has arisen for the position of Manufacturing Biotech Associate at our single-use Dunboyne facility.

As a Biotech Associate you will be part of a self-directed work team in Downstream Operations, responsible for all procedures and processes associated with the manufacture of Drug Substance. The Manufacturing Biotech Associate leads by example by always upholding the highest standards of Safety, Quality, GMP, Right First Time and Compliance.

Key responsibilities include the execution of an automated recipe using paperless technology to progress the drug substance through inoculation and cell culturing activities, leading to filtration and purification of the product in a single use technology-based facility.

The Biotech Associate will also be involved in optimising and improving processing activities through use of standard work and lean processing techniques, while consistently delivering on specific KPI’s. This role is focused on delivery to the patient through living the Dunboyne culture, including a commitment to safety, right first time in everything we do, and a focus on the engagement and development of self and peers.

In addition to the above, the Manufacturing Biotech Associate will need to:

• Be strong technically, with an excellent ability to grasp processes and procedures. Aspiring to be an SME across the Downstream business unit, be strongly motivated to acquire knowledge and understand all Downstream processes to a micro level

• Be approachable, supportive, inclusive to other team members, while striving to work in a cohesive and proactive team, with a ‘never let a teammate fail’ mindset

• Display flexibility, adaptability, innovation, with an ability to think on your feet, also possess a strong skill set for logical root cause analysis, and problem solving

• Be an excellent communicator, and true team player with concern for others

• Be able to deliver business unit goals through close collaboration with their team members, but also with colleagues across other departments

• Display high initiative, daily seeks the production schedule, and helps lay plans to achieve it

• Takes part in shift handovers and Tier meetings, raising any concerns or issues promptly and providing options for resolutions.

• Be actively involved by participating in inspections, GEMBA’s and Go-See’s, improvement projects and other initiatives

• Perform documentation tasks as authorised, and any other administrative tasks as directed by your manager

• Aspire to become proficient with production systems such as MES, DeltaV, SAP, GLIMS, PROCAL and others

• Deputised if required, to represent the department at meetings and discussions, and performs any other duties as appropriate when assigned by the Manager

What skills you will need:

To excel in this role, you will more than likely have:

• A Level 7, or higher, qualification in a science, engineering or technical discipline

• Relevant experience in a GMP, or regulated Cleanroom manufacturing environment (experience a definite advantage)

• Excellent communication skills and the ability to work in a cross functional collaborative team

• A willingness to learn, adapt, gain knowledge, and train others when fully proficient

• Willingness and ability to work 24/7 shift operations, which include 12-hour shifts of days, nights and weekend work in rotation

• Be able to demonstrate research or knowledge of the overall Upstream and Downstream processes, and in particular Downstream processes

• Good PC skills, with an ability to work with automated business or manufacturing systems

• Knowledge and understanding of GMP and quality systems

• Troubleshooting and problem-solving competency

• Desire to learn and develop. Ability to interact with multiple stakeholders across numerous departments

• Knowledge and experience of Kanban, JIT, 5S and Lean Manufacturing methodologies would be an advantage

• Ability to manage multiple priorities and know when to escalate issues for resolution.

• A proven ability to deliver on tight timelines

This position will support the manufacturing shift team to deliver batch operations successfully,

Required Skills:

Accountability, Adaptability, Computer Literacy, Data Entry, Equipment Maintenance, General Safety, Good Manufacturing Practices (GMP), Lean Manufacturing, Manufacturing Operations, Operations Management, Safety Standards, Stakeholder Relationship Management, Standard Operating Procedure (SOP) Writing, Sterilizing Equipment, Team Operations

Preferred Skills:

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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:

01/24/2026

*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.