Operations Specialist, Manufacturing Support

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.

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. 

Required Skills:

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