Vaccine Manufacturing Operations Specialist

MSD Malaysia; Ireland; Remote; EUR 70,000 - 95,000; Full time

Job summary

MSD Ireland seeks an Operations Specialist, Manufacturing Support for its vaccine facility in Dundalk, Ireland. You will troubleshoot, monitor processes, drive deviations, perform risk assessments, manage documentation, and contribute to continuous improvement to ensure Right First Time performance.

Requirements include a Bachelor's in Engineering/Science or related field and 3+ years in a cGMP biotech/pharma setting, with experience in regulatory and quality systems.

Qualifications

• Bachelor's degree in Engineering, Science or related discipline, or equivalent experience.
• Minimum 3 years in a cGMP biological, vaccine or pharma facility.
• cGMP experience with biological or vaccine manufacturing is an advantage.
• Ability to operate in a matrix team on floor activities (FAT, SAT, IQ/OQ).
• Experience leading complex technical investigations.
• Risk-based approach to manufacturing using tools like FMEA.
• Strong planning skills and adaptability.
• Understanding USP1790 and industry/regulatory expectations.
• Experience with AVI/MVI and library of defects is an advantage.
• Data-driven root-cause analysis and Six Sigma/Lean knowledge.

Responsibilities

• Provide technical support within Drug Product Manufacturing for Formulation, Filling, Lyophilisation, Capping and AVI.
• Support manufacturing deliverables to enable product launches.
• Assist operations during APS, engineering batches and commercial manufacturing.
• Lead/participate in investigations with cross-functional teams for root-cause and CAPAs.
• Lead deviation root-cause analysis and impact assessments.
• Explain complex technical issues to external customers/ agencies.
• Support Batch Disposition with SME technical input.
• Identify and implement projects to improve compliance and manufacturing capabilities.
• Create and revise technical docs: batch records, risk assessments, SOPs, memos.
• Support equipment qualification during project phases (IOQ, IQ/OQ, FAT/SAT).
• Participate in regulatory, client and internal audits 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

Job description

MSD Ireland seeks an Operations Specialist, Manufacturing Support for its vaccine facility in Dundalk, Ireland. You will troubleshoot, monitor processes, drive deviations, perform risk assessments, manage documentation, and contribute to continuous improvement to ensure Right First Time performance.

Requirements include a Bachelor's in Engineering/Science or related field and 3+ years in a cGMP biotech/pharma setting, with experience in regulatory and quality systems.