Process Engineer

Job Title: Process Engineer (MS&T )-23803Location: Dublin, IrelandType: Contract (Hybrid working-3 days Onsite)Pay rate: 40 – 52 Euros per hourJob Purpose

The MS&T Process Engineer provides technical support to the Drug Substance business, leading investigations, supporting site projects, and facilitating new product introductions (NPI), technology transfers, and commercialization activities. The role involves design, construction, and qualification of upstream and downstream equipment, ensuring compliance with cGMP, safety, and regulatory requirements. The Process Engineer drives continuous improvement and fosters a culture of collaboration and excellence.

Primary Responsibilities

• Ensure compliance with global policies, regulatory requirements, and current Good Manufacturing Practices (cGMP) in all daily activities.
• Design, author, review, approve, and execute qualification documentation in line with standards.
• Lead experimental design, execution, data analysis, and author technical and regulatory documents.
• Interpret trends in commercial process monitoring (e.g., PPA, CPV, SPC, MVDA) to identify improvements in yield and robustness.
• Support execution of development and PPQ batches, change control management, and implementation.
• Lead multidisciplinary teams (MS&T, Quality, Analytics, Regulatory) in process improvement and troubleshooting using Lean Six Sigma methodologies.
• Drive investigations through effective Root Cause Analysis and CAPA management.
• Act as SME during audits and inspections.
• Support and lead site initiatives to enhance compliance, efficiency, and overall operational performance.
• Participate in organizational initiatives such as safety, work standardization, and financial forecasting.
• Maintain strong focus on safety, quality, and customer needs.

Qualifications and Experience1. General Competencies

• Demonstrated leadership and change management skills with a focus on continuous improvement.
• Proven ability to deliver results through coaching and team development.
• Strong collaboration skills with a track record of promoting knowledge sharing.
• Motivation to contribute to high-performing teams and build long-term success.
• Excellent interpersonal skills: flexibility, collaboration, inclusion, and coaching ability.
• Evidence of continuous professional development.

2 Technical Skills

• Subject Matter Expertise in upstream/downstream processing and process control strategies.
• Knowledge of process monitoring systems, automation systems (e.g., DeltaV), and operational intelligence/data systems (e.g., Pi System) in GMP environments.
• Familiarity with regulatory requirements to Irish, European, and International standards.
• Proficiency in technical writing and documentation.
• Strong ability to explain and apply biologics processes for decision-making, impact assessments, and study design.
• Working knowledge of SPC, MVDA, and/or PAT techniques for biologics processes.

3 Education & Experience

• Degree in Applied Pharmaceutical, Biological, Chemical Sciences, Engineering, or equivalent technical qualification.
• Experience leading technical projects in commercial-scale biologics manufacturing.
• Hands-on experience in upstream cell culture and/or downstream purification.
• Familiarity with regulatory audits and ability to act as SME.
• Experience in technology transfer, regulatory filings, and drug substance commercialization.
• Prior involvement in process development, characterization, validation, and site readiness.
• Strong background in change management, deviation handling, and CAPA management.