Sr. Tech, Operations

Msd Ireland; Dunboyne; On-site; EUR 75,000 - 90,000; Full time

Job summary

MSD Ireland is seeking a Senior Manufacturing Biotech Associate for our Dunboyne single-use facility. You will be a self-directed team member in Solution Prep Operations, responsible for drug substance manufacturing processes.

The role requires 24/5 shift operations (days/nights and rotations) and site-based work, with opportunities to mentor colleagues and lead local teams while coordinating with other departments in a matrix setup.

Qualifications

• 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 and the ability to work in a cross functional collaborative team.
• Possess a detailed overview of the overall Upstream and Downstream processes, with particular expertise in Downstream manufacturing.
• Maintain a high level of expertise and working knowledge of the process equipment.
• Experience with automated systems such as MES, SAP, DeltaV; knowledge of GMP and quality systems.

Responsibilities

• Be technically strong with processes and procedures, acting as SME on multiple processes.
• Train, coach and mentor less experienced team members to foster a cohesive team.
• Demonstrate flexibility, problem solving and root-cause analysis to support CI.
• Lead local work teams and collaborate with other departments within a matrix organization.
• Monitor production schedules, plan to meet or exceed timelines, and participate in handovers and meetings.
• Engage in inspections, GEMBA walks, Go-See events and continuous improvement initiatives.
• Perform EBR and documentation reviews and assist with investigations and closure.
• Represent the department in meetings when deputised by the Manager.

Skills

Cross-functional collaboration

Communication skills

Problem solving

Lean manufacturing

Kanban

JIT

Education

Level 7 or higher in science/engineering

Tools

MES

SAP

DeltaV

GLIMS

Job description

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 and the ability to work in a cross functional collaborative team
• Possess a detailed overview of the overall Upstream and Downstream processes, with particular expertise and working knowledge of the Downstream manufacturing process
• Maintain a high level of expertise and working knowledge of the process equipment.
• A proven ability to work with automated systems such as Manufacturing Execution System (MES), Systems Applications and Products (SAP), Delta V etc.
• Strong knowledge and understanding of manufacturing GMP and quality systems
• Demonstrate 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
• Ability to manage multiple priorities and know when to escal…
• Excellent trouble shooting skills as well as an ability to coach and mentor self-directed teams through complex problem solving. High degree of problem-solving ability and adherence to scheduled timelines.
• 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 diverse, 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.

Required Skills

Biopharmaceutical Manufacturing, Cross-Functional Collaboration, Downstream Operations, GMP Operations, Manufacturing Execution Systems (MES), Prioritization, SAP Applications, Solution Preparations, Teamwork, Upstream Operations

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

Yes

Travel Requirements

No Travel Required

Flexible Work Arrangements

Not Applicable

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

NA