Manufacturing Biotech Associate

Merck Sharp & Dohme Corp.; Dunboyne; A distancia; EUR 52.000 - 76.000; Jornada completa

Descripción de la vacante

Merck Gruppe - MSD Sharp & Dohme seeks a Manufacturing Biotech Associate for its Dunboyne site. You will be part of a self-directed Downstream Operations team responsible for Drug Substance manufacturing, upholding Safety, Quality, GMP and Right First Time.

The role requires 24/7 shift work and strong collaboration across teams. You will develop expertise in downstream processes, participate in inspections and continuous improvement projects, and contribute to producing medicines at scale with a

Formación

• Bachelor-level qualification in science, engineering or technical discipline.
• Experience in GMP or regulated cleanroom manufacturing is advantageous.
• Excellent communication and ability to work in cross-functional teams.

Responsabilidades

• Be technically strong with understanding Downstream processes to a micro level.
• Be approachable and supportive to team members in a proactive team environment.
• Demonstrate root cause analysis and problem-solving skills.
• Deliver business unit goals through collaboration across departments.
• Take initiative to align with the production schedule and plan accordingly.
• Participate in shift handovers and Tier meetings, raising concerns with options.
• Be actively involved in inspections, GEMBA/Go-See visits and improvement projects.
• Perform documentation tasks and other admin duties as directed by the Manager.
• Aim to become proficient with MES, DeltaV, SAP, GLIMS, PROCAL and similar systems.
• Deputise to represent the department in meetings as needed.

Conocimientos

Strong communication

Cross-functional teamwork

Problem solving

Adaptability

Initiative

Compliance & GMP

Documentation discipline

Educación

Bachelor-level in science/engineering

Herramientas

MES

DeltaV

SAP

GLIMS

PROCAL

Descripción del empleo

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.

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

• 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

What skills you will need:

In order 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

• 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 escalation 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.

Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

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.

Please feel free to speak to us about what flexibility means to you during your application.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs,

Required Skills:

Biotechnology Manufacturing, GMP Documentation, Good Manufacturing Practices (GMP), Kanban, Manufacturing Documentation, Manufacturing Operations, Multidisciplinary Teamwork, Pharmaceutical Manufacturing, Problem Solving

Preferred Skills:

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Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Yes

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

3rd - Night

Valid Driving License:

No

Hazardous Material(s):

NA