Senior Process Engineer

Orion Group Life Sciences are recruiting a Senior Process Engineer for a multinational biopharmaceutical client based in Dublin. The role is an initial 11-month contract with potential extension.

Job Purpose:

The MS&T Process Engineer provides technical support to the Drug Substance Business, leading technical investigations within the Integrated Process Team, supporting major site projects, and assisting with design, construction and qualification of upstream and downstream equipment (where applicable), NPI/technology transfer, and commercialization activities. The MS&T Process Engineer ensures team objectives are met in compliance with safety, quality, and reliability requirements, while promoting an inclusive culture focused on Safety First, Quality Always, and continuous improvement.

• Drive compliance with Global Policies, Procedures and Guidelines, regulatory requirements and cGMP in day-to-day activities and all applicable job functions, considering GMP and compliance in decision-making.
• Design/Author/Review/Approve/Execute qualification documentation in line with standard processes.
• Lead experimental design of studies, execution, data analysis and interpretation. Author and review batch documentation, regulatory and technical documentation.
• Interpret trends in commercial process monitoring (e.g., PPA, CPV, SPC, MVDA) and support further technical investigations and process changes to improve yield and robustness.
• Support execution of development and PPQ batches, change control management and implementation.
• Lead multidisciplinary teams for process improvement and troubleshooting with end-to-end product focus using Lean Six Sigma methodologies.
• Lead and facilitate investigations with effective Root Cause Analysis and CAPAs. Participate in audits and inspections.
• Lead or support site initiatives to improve compliance and overall operational efficiency; act as a key member during internal and external audits/inspections.
• Lead and support MS&T organizational initiatives (e.g., safety, financial forecasting, work standardization).
• Maintain continuous focus on quality, safety compliance, and customer satisfaction.

• Demonstrated leadership and change management with a continuous improvement mindset.
• Proven track record of developing and coaching teams to high performance.
• Evidence of continuous professional development and collaboration to share knowledge and best practices across the site.
• Desire to contribute to the future success of the organization and to be an inspiring member of a high-performing team.
• Willingness to continuously learn, improve, and develop; strong interpersonal skills including flexibility, collaboration, inclusion, and the ability to work in, upskill, and coach within a team.

• Subject Matter Expert in upstream/downstream processing and process control; working knowledge of analytics.
• Knowledge of process monitoring systems, automation systems (e.g., DeltaV), operational intelligence & data systems (e.g., Pi System) within a GMP environment.
• Knowledge of regulatory/code requirements per Irish, European, and international standards.
• Strong technical writing skills; ability to articulate an understanding of biologics processes to drive decision-making and design of studies in a multidisciplinary team.
• Working knowledge of SPC, MVDA, and/or PAT techniques for biologics processes.
• Technical qualifications in Applied Pharmaceutical/Biological/Chemical sciences or related engineering field.
• Experience leading technically focused projects; experience with upstream cell culture and/or downstream purification of biological molecules.
• Experience presenting in front of regulatory audits as an SME; experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus.
• Technical operations experience in drug substance manufacturing of biological molecules at commercial scale.
• Experience in drug substance process development, process characterization, PPQ/validation, site readiness, batch record reviews, regulatory CTD authoring, and working with external contract organizations for development/manufacturing.
• Experience in change management, deviations, and CAPA management.

• Mid-Senior level

• Contract

• Industries
• Pharmaceutical Manufacturing