Operations Specialist, Manufacturing Support

MSD; Leinster; On-site; EUR 60,000 - 95,000; Full time

Job summary

MSD in Dundalk, Ireland, is seeking an Operations Specialist, Manufacturing Support to join our Drug Product manufacturing team at a state-of-the-art vaccine facility. You will troubleshoot, monitor processes, investigate deviations, manage documentation, and support readiness activities including engineering batches, process validation, and technology transfer.

The role requires a Bachelor's in Engineering or Science and at least 3 years in a cGMP pharma setting; experience with aseptic

Qualifications

• Bachelor's degree in Engineering, Science or related discipline or equivalent experience.
• Minimum 3 years in a cGMP biological, vaccine or pharma facility.
• Experience with aseptic manufacturing is advantageous.
• Able to operate in a matrix team for floor activities (FAT, SAT, IQ/OQ).
• Experience leading complex technical investigations.
• Risk-based manufacturing using tools like FMEA.
• Strong planning skills and ability to adapt to changing priorities.
• Understanding USP1790 and industry/regulatory expectations.

Responsibilities

• Provide technical support across Drug Product manufacturing areas including Formulation, Filling, Lyophilisation, Capping and AVI.
• Support operations during APS, engineering batches and commercial manufacturing.
• Lead/participate in investigations to ensure root cause analysis and CAPAs.
• Lead deviation RCA and impact assessments.
• Explain complex technical issues to external customers/agencies.
• Support batch disposition with SME input.
• Identify and implement projects to improve compliance and DP Upstream capabilities.
• Create and revise technical documents (batch records, risk assessments, SOPs, memorandums).
• Support equipment qualification during IOQ/IQ and project phases.
• Participate in regulatory, client and internal audits inspections as technical representative.

Skills

cGMP Compliance

Operational Qualification

Operations Support

Process Optimization

Regulatory Compliance

Root Cause Investigations

Technical Writing

Training and Development

Education

Bachelor's degree in Engineering, Science or related discipline

Tools

AVI/MVI

FMEA

Job description

Job Description

A fantastic opportunity has arisen for an Operations Specialist, Manufacturing Support within our Drug Product manufacturing 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.

The Operations Specialist will play a key role in supporting day-to-day manufacturing through troubleshooting, process monitoring, deviation investigation, risk assessment, documentation management, and continuous improvement. The role also contributes to readiness activities including engineering batches, process validation, APS, technology transfer, and commercial manufacturing preparations, helping to strengthen manufacturing capability and Right First Time performance.

Bring energy, knowledge, innovation to carry out the following

• Providing technical support within the Drug Product Manufacturing team, including areas such as Formulation, Filling, Lyophilisation, Capping, and Automated Visual Inspection. Supporting manufacturing deliverables within Drug Product to support the successful product launch.
• Providing technical support to the operations teams during Aseptic Process Simulation (APS), engineering batches, and commercial manufacturing.
• Providing technical support for (Right First Time) RFT implementation and execution.
• Leading/participating in manufacturing investigations with cross-functional teams to ensure that detailed root cause analysis is completed, and appropriate CAPAs are implemented.
• Leading deviation root cause analysis and impact assessments.
• Explaining complex technical issues to external customers / agencies.
• Supporting Batch Disposition activities by providing SME technical support for comment resolution.
• Identification and implementation of projects to continuously improve the compliance and manufacturing capabilities within the DP Upstream Manufacturing area.
• Creating and revising technical documents including manufacturing batch records, Risk Assessments, SOPs, and technical memorandums.
• Supporting equipment qualification deliverables during execution of project phase including equipment Commissioning & Qualification, Installation & Operational Qualification (IOQ).
• Participating in Regulatory, Client and Internal audits inspections as the technical representative.

What Skills You Will Need

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

• Bachelor's degree in Engineering, Science or related discipline or, relevant proven experience.
• Minimum 3 years working in a cGMP biological, vaccine or pharma facility.
• cGMP experience with biological, vaccine or pharma facility with prior aseptic manufacturing experience is an advantage.
• Ability to operate within a matrix team to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches.
• Experience in leading and resolving complex technical investigations.
• Experience in a risk-based approach to manufacturing through the use of tools such as FMEA.
• Demonstrated skills in planning skills are mandatory.
• Ability to adapt to changing priorities as project demands change.
• Understanding USP1790 and industry/ regulatory.
• Experience with AVI/MVI and creation of library of defects is an advantage.
• Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e.g., Six Sigma, Leam Manufacturing.

Required Skills

cGMP Compliance, Operational Qualification, Operations Support, Process Optimization, Regulatory Compliance, Root Cause Investigations, Technical Writing, Training and Development

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

Job Posting End Date

09/22/2026

• A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID R416005