Vaccine Manufacturing Operations Specialist

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

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