Manufacturing Biotech Associate

Merck; Ireland; On-site; EUR 40,000 - 70,000; Full time

Benefits offered by this job

Hybrid working model

Job summary

Merck's Dunboyne site seeks a Manufacturing Biotech Associate to join the Downstream Operations team. The role focuses on Drug Substance manufacture within a single‑use facility, maintaining high safety, quality, GMP and compliance standards.

The position requires flexibility to work 24/7 shifts and is site‑based. You will collaborate cross‑functionally to grasp processes at a micro level, contribute to process improvements, and support production goals while upholding a culture of teamwork and

Qualifications

• A Level 7 or higher qualification in science, engineering or technical discipline.
• Experience in GMP or regulated Cleanroom manufacturing is advantageous.
• Excellent communication and cross-functional collaboration skills.
• Willingness to learn, adapt and train others to proficiency.
• Knowledge of Upstream/Downstream processes, especially Downstream processes.

Responsibilities

• Operate within a self‑directed team to manufacture Drug Substance.
• Uphold Safety, Quality, GMP and Right First Time standards.
• Participate in 24/7 shift operations including days, nights, and rotations.
• Deliver shift handovers, Tier meetings and issue resolutions promptly.
• Collaborate with departments to meet production schedules and business unit goals.
• Engage in inspections, GEMBA walks, improvements and Go‑See activities.

Skills

GMP standards

Cross-functional teamwork

Problem solving

Communication skills

Shift work flexibility

Lean manufacturing

Downstream knowledge

Education

Level 7 or higher in science/engineering/technical discipline

Tools

MES

DeltaV

SAP

GLIMS

PROCAL

Job description

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.

Ability to work 24/7 shift operations, which include days, nights and in rotation is required.

This role is a site‑based role.

Key Responsibilities

• 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
• 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

Required Skills

• 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
• 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 elevate issues for resolution
• A proven ability to deliver on tight timelines

Our facility in Dunboyne joined our network in September 2020. Our Dunboyne site is our Company's first Biologics Drug Substance Single Use Commercialisation Facility, playing an important role in helping to commercialise key medicines. The cutting‑edge innovation and collaboration between our Company's research and manufacturing teams will significantly accelerate the time it takes to bring a medicine to market for the benefit of patients around the world.

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 talented and committed people together.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office‑based colleagues around the world.