A new opportunity has opened within a growing Manufacturing, Science & Technology  team for a Senior Process Engineer to support Upstream Manufacturing operations at a cutting-edge biologics facility in Dublin.
This is a 6-month contract role to help manage an increased workload, supporting critical operations that contribute to delivering life-saving medicines to patients worldwide.

WHY APPLY?

This role offers the chance to work on diverse and impactful projects, including manufacturing support, new product introductions, technology transfers, and regulatory submissions. It’s a great opportunity for someone looking to apply their technical expertise in a fast-paced, innovative environment with a global reach.

KEY RESPONSIBILITIES:

As part of a collaborative, cross-functional team, you’ll bring energy, expertise, and leadership to:

• Lead and support investigations using effective Root Cause Analysis (RCA), data interpretation, and CAPA implementation to resolve complex upstream (cell culture) deviations.
• Drive process improvements with a holistic, end-to-end product focus.
• Support digital transformation initiatives and industry 4.0 adoption in data analytics and operations.
• Provide technical leadership for the introduction of new processes or implementation of changes in commercial manufacturing.
• Prepare and review batch records, technical reports, and regulatory documentation.
• Guide and mentor members of the process engineering and manufacturing teams.
• Analyze and interpret trends from commercial process monitoring activities (e.g., statistical process control, continued process verification, multivariate analysis).
• Lead and contribute to site-wide initiatives aimed at improving compliance and operational efficiency.
• Support execution and analysis of development and PPQ batches.
• Identify risks and troubleshoot issues in a timely manner to ensure project timelines are met.

KEY REQUIREMENTS:

To succeed in this role, you should bring:

• Strong experience in upstream processing within biologics manufacturing.
• Proven ability to lead complex investigations and support regulatory inspections.
• Solid background in technology transfers, regulatory filings, and commercial manufacturing operations.
• Strong communication, project management, and cross-functional leadership skills.
• Experience applying Lean Six Sigma and Change Management tools.
• Proficiency in identifying and implementing process improvements and driving change initiatives.
• Ability to work independently and contribute effectively in multidisciplinary teams.
• Knowledge of current GMP regulations and compliance standards in biopharma.

• Bachelor’s degree (or higher) in Science, Engineering, or a related technical discipline.
• Minimum of 5 years’ experience in a biopharmaceutical manufacturing environment, or 4 years with a focus in technical support.
• Direct experience in upstream biologics manufacturing, facility commissioning, validation, and startup.