BioProcess Associate - Fill Finish

MSD Ireland; Leinster; On-site; EUR 45,000 - 65,000; Full time

Job summary

MSD Ireland is seeking a BioProcess Associate to join the Drug Product team at our Dundalk vaccine facility. You will perform core production activities, operate equipment for formulation and fill/finish processes, and support qualification and start-up activities for new equipment.

You will work in a fast-paced, regulated environment, maintaining cGMP standards and contributing to KPI delivery across Safety, Quality, and Schedule Adherence.

Qualifications

• Bachelor’s or higher in science, engineering, or equivalent.
• Minimum 3 years’ experience in a regulated environment.
• Experience following SOPs, batch records, and manufacturing control systems is desirable.
• Strong communication, attention to detail, documentation, and problem-solving skills.

Responsibilities

• Perform core production activities in the Drug Product facility.
• Operate equipment for formulation, filling, lyophilization, capping, and inspection.
• Support commissioning, qualification, validation, and start-up activities for new equipment and processes.
• Complete manufacturing tasks in line with SOPs and batch records, both paper and electronic.
• Maintain a safe and cGMP-compliant work environment.
• Troubleshoot routine issues and support deviation investigations through the Quality System.
• Write, review, and revise SOPs, batch records, logbooks, training competencies, work instructions, and job aids.
• Support Continuous Improvement initiatives using Lean/Six Sigma tools and Standard Work principles.
• Provide updates during shift handovers and contribute to team KPI delivery, including Safety, Quality, Schedule Adherence, OEE, and training.
• Support Maintenance, Engineering, Quality, and other functions as needed.

Skills

GMP Experience

Teamwork

Documentation

Problem solving

Communication

Education

Science/Engineering degree

Job description

We are looking for a BioProcess Associate to join our Drug Product team at our state-of-the-art, fully integrated vaccine facility in Dundalk, Ireland. This is an exciting opportunity to be part of a fast-growing, dynamic team working with cutting-edge technology at the forefront of vaccine manufacturing.

Bring Energy, Knowledge, Innovation To Carry Out The Following

• Perform core production activities in the Drug Product facility.
• Operate equipment for formulation, filling, lyophilization, capping, and inspection.
• Support commissioning, qualification, validation, and start-up activities for new equipment and processes.
• Complete manufacturing tasks in line with SOPs and batch records, both paper and electronic.
• Maintain a safe and cGMP-compliant work environment.
• Troubleshoot routine issues and support deviation investigations through the Quality System.
• Write, review, and revise SOPs, batch records, logbooks, training competencies, work instructions, and job aids.
• Support Continuous Improvement initiatives using Lean/Six Sigma tools and Standard Work principles.
• Provide updates during shift handovers and contribute to team KPI delivery, including Safety, Quality, Schedule Adherence, OEE, and training.
• Support Maintenance, Engineering, Quality, and other functions as needed.

What Skills You Will Need

In order to excel in this role, you will more than likely have:

• Certificate, Diploma, Degree, Trade qualification in Science, Engineering, or equivalent.
• 3 years’ experience in a regulated environment.
• Experience working as part of a team and recording information in real time using electronic or manual systems.
• Experience following SOPs, batch records, and manufacturing control systems is desirable.
• Strong communication, attention to detail, documentation, and problem-solving skills.
• Ability to work independently and as part of a self-managed shift team in a fast-paced environment.

Preferred

• Experience in the biopharmaceutical industry.
• Experience working in Grade B, C, D, and CNC environments.
• Experience in Drug Product operations.
• Experience in a fast-paced project environment.

As a cutting-edge, state-of-the-art vaccines facility spanning over 15,500 square metres across three stories, our Dundalk site will focus on qualification, continued product development and expanding its capabilities within our network. Featuring drug substance manufacturing, drug product manufacturing and quality control labs that will support the global supply of vaccine products - strengthening our ability to make an impact on people and patients worldwide by adding new capabilities to our already industry-leading network.

Our Companies in Ireland is one of the country’s leading healthcare companies, having first established here 50 years ago. The company has a dynamic and inclusive team of over 4,000 employees currently working across eight locations in Ballydine, Co. Tipperary, Brinny, Co. Cork, Dunboyne, Co. Meath, Dundalk, Co. Louth, Carlow and Dublin, and, in addition, operate substantial Human Health and Animal Health businesses. We work at the forefront of science and technology to advance manufacturing excellence and R&D across our Irish sites and global company network.

Required Skills

Cleanroom Gowning, Drug Product Manufacturing, Good Manufacturing Practices (GMP), Shift Work

Secondary Language(s) Job Description

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 inclusive, 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.

Employee Status

Regular

Flexible Work Arrangements

Not Applicable