Senior Process Specialist

Job Title: Process Engineer Specialist (Contract)

Location: Dublin, Ireland

Start Date: Fixed start date – First week of January 2027

Working Arrangement: Hybrid – 3 days onsite and 2 days remote

About the Opportunity

We are seeking an experienced Senior Specialist – Process Engineering to join a major biotechnology facility development project in Dublin.

This is an exciting opportunity to contribute to the development of a state-of-the-art, large-scale mammalian-based drug substance manufacturing facility. The successful candidate will play a key role in shaping the facility's engineering, process development, qualification and operational readiness, supporting the manufacture of innovative biologic medicines.

The role will involve working with multidisciplinary teams across manufacturing science and technology, engineering, quality, analytics and regulatory functions.

Key Responsibilities

• Support the design, construction and qualification of upstream and downstream manufacturing equipment through technology transfer and commercialisation.
• Support the establishment of commercial manufacturing processes and routine operations.
• Plan and execute experiments, analyse process data and interpret results to support process understanding and improvements.
• Review process monitoring trends, including Continued Process Verification (CPV), Statistical Process Control (SPC), multivariate data analysis (MVDA) and process performance monitoring.
• Conduct technical investigations and identify opportunities to improve process yield, efficiency and robustness.
• Support deviation investigations, change control prioritisation and implementation.
• Author and review batch documentation, technical reports and regulatory submission documents.
• Collaborate with cross-functional teams to troubleshoot manufacturing issues and drive continuous process improvement.
• Apply Lean Six Sigma tools to facilitate problem-solving, risk assessments and FMEA activities.
• Support internal audits, external inspections and regulatory compliance activities.
• Contribute to wider manufacturing science and technology initiatives, including safety, financial forecasting and work standardisation.
• Maintain a strong focus on GMP compliance, quality, safety and continuous improvement.

Essential Requirements

• Minimum 5 years' relevant experience with an MSc or 7 years' relevant experience with a BSc in academia, pharmaceutical or biotechnology environments.
• Bachelor's degree or higher in Biological Sciences, Chemical Engineering, Biological Engineering, Chemistry or a related discipline.
• Strong understanding of current GMP requirements and pharmaceutical/biotechnology regulatory expectations.
• Experience working independently and collaboratively within multidisciplinary teams.
• Excellent technical, communication, documentation and problem-solving skills.
• Ability to manage priorities, meet project timelines and take ownership of deliverables.

Preferred Experience and Skills

• Experience in upstream cell culture and/or downstream purification of biological molecules.
• Experience in biologics drug substance manufacturing, preferably at commercial scale.
• Exposure to technology transfer, commercialisation and regulatory submissions.
• Experience with process development, process characterisation, process performance qualification and validation.
• Experience with site readiness, batch record reviews and technical documentation.
• Experience working with Contract Manufacturing Organisations (CMOs) or external development/manufacturing partners.
• Knowledge of Design of Experiments (DoE) and statistical analysis tools such as JMP or Design Expert.
• Understanding of SPC, MVDA and Process Analytical Technology (PAT) within biologics manufacturing.