A premier global biopharmaceutical organization is seeking an accomplished Senior Specialist, Process Engineering to join its state-of-the-art biologics facility in Dublin. In this pivotal technical role, you will champion the design, qualification, technology transfer, and commercial lifecycle management of upstream and downstream manufacturing processes.
Serving as a subject matter expert within MS&T, you will partner cross-functionally to drive technical investigations, advance yield and process robustness, author regulatory filings, and support regulatory audits in a high-performing commercial environment.
Key Responsibilities
- Facility & Process Delivery: Drive design, qualification, and commissioning of upstream and downstream equipment through tech transfer to commercial readiness.
- Commercial Process Science: Oversee proactive process monitoring (CPV, SPC, MVDA), identify trend shifts, lead complex deviation investigations, and execute data-driven change controls to optimize yield and robustness.
- Experimental Design & Optimization: Direct DOE, laboratory-scale studies, data modeling, and statistical analysis to troubleshoot operations and streamline routine manufacturing.
- Technical & Regulatory Documentation: Author and review master batch records, technical/campaign reports, FMEA risk assessments, and CTD sections for global regulatory submissions.
- Continuous Improvement: Utilize Lean Six Sigma tools to drive root-cause analysis, reduce process variability, and lead MS&T organizational initiatives.
- Audit & Inspection Readiness: Act as a key technical SME during internal audits and health authority regulatory inspections (e.g., FDA, HPRA/EMA).
Candidate Profile
- Education: Bachelor's, Master's, or PhD in Chemical Engineering, Biochemical Engineering, Biotechnology, Biological Sciences, Chemistry, or a related discipline.
- Experience Requirements:
- BSc: 7+ years of relevant industry experience in biopharmaceutical/biotechnology manufacturing science or process engineering.
- MSc: 5+ years of directly applicable bioprocess experience.
- PhD: Strong academic research/development background in process science or relevant post-doctoral experience.
- Technical Mastery: Solid foundation in cGMP, global regulatory requirements, and technical operations for commercial drug substance manufacturing (cell culture or purification).
- Statistical Tools: Proficiency in statistical methodologies, DOE software (JMP, Design-Expert), multivariate data analysis (MVDA), or Process Analytical Technology (PAT).
- Leadership & Collaboration: Proven capability to lead multi-disciplinary teams, hold stakeholders accountable to project milestones, and translate complex process science into clear, actionable decisions.
Desirable Experience
- Direct hands-on background in commercial-scale biologics drug substance operations (upstream cell culture or downstream purification).
- End-to-end exposure to Process Performance Qualification (PPQ), process characterization, and site-readiness programs.
- Demonstrated track record managing contract manufacturing organizations (CDMOs) or authoring Module 3 regulatory submissions.
