Sr. Tech, Operations

Merck Gruppe - MSD Sharp & Dohme; Dunboyne; Remote; EUR 65,000 - 80,000; Full time

Job summary

Merck Gruppe - MSD Sharp & Dohme is seeking a Senior Manufacturing Biotech Associate for our Dunboyne facility in Meath, Ireland. You will be part of a self-directed team in Solution Prep Operations, overseeing Drug Substance manufacture and maintaining quality in a GMP environment.

The role requires 24/5 shift coverage, including days and nights, and involves leading local work teams, coaching colleagues, and driving continuous improvement through Lean Six Sigma and robust documentation

Qualifications

• A Level 7, or higher, qualification in a science or engineering discipline.
• Minimum 3 years’ experience in a GMP regulated manufacturing environment.
• Strong communication skills.

Responsibilities

• Lead and mentor team members, promoting a cohesive, proactive work environment.
• Own and apply Lean Six Sigma tools to drive continuous improvement.
• Act as SME for production systems (MES, DeltaV, SAP, GLIMS, PROCAL).
• Coordinate shift handovers, attend Tier meetings, and support inspections.
• Collaborate across departments in a matrix reporting environment to meet production goals.
• Support documentation reviews and investigations as directed.

Skills

Leadership

Mentoring

Problem solving

Lean Six Sigma

Manufacturing GMP

Communication

Production systems SME

Education

Level 7 qualification in science or engineering

Tools

MES

DeltaV

SAP

GLIMS

PROCAL

Job description

Location Dunboyne, Meath, Ireland Job Type Full time

Job Description

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

As Senior Biotech Associate you will be part of a self-directed work team in Solution Prep Operations, responsible for all procedures and processes associated with the manufacture of Drug Substance.

Ability to work 24/5 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:

• As a senior team member, be strong technically, with an excellent grasp of processes and procedures. Already an SME on many processes, be strongly motivated to acquire knowledge and understand all Downstream processes to a micro level
• Proactively train, coach and mentor less experienced team members, by being approachable, supportive, inclusive and generous with knowledge, while striving to work in a cohesive and proactive team, with a ‘never let a teammate fail’ mindset
• Display flexibility, adaptability, innovation, with a reflexive ability to think on your feet, also possess a strong skill set for logical root cause analysis, and problem solving
• Be able to organise and lead local work teams, also deliver business unit goals through strong and cohesive collaboration with other departments, within a matrix reporting environment
• Display high initiative and be ready to take responsibility; thinks ahead, seeks the production schedule daily, organises local work teams and lays plans to achieve or exceed the schedule
• Takes part in shift handovers and Tier meetings, raising concerns or issues promptly and providing options for resolutions.
• Be actively involved by participating in inspections, GEMBA’s and Go-See’s, OPPS, improvement projects and other MPS initiatives
• Perform EBR and documentation reviews, QN investigation and closure, and any other documentation or administrative tasks as directed by your manager
• Utilise Lean Six Sigma Tools to support the initiative of continuous improvement (CI)
• Be proficient to SME level with production systems such as MES, DeltaV, SAP, GLIMS, PROCAL and others
• Deputised when 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 or engineering discipline, with a minimum of 3 years’ experience in a GMP regulated Manufacturing environment.
• Strong experience in a highly regulated pharmaceutical manufacturing environment
• Excellent communication skills