Senior Process Engineer Cork, Ireland Hybrid

Job description

Back to Jobs Cork BioMarin Pharmaceutical Who We Are BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions. Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world. About Technical Operations BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Senior Process Engineer Commerical Support, Technical Development Location: Shanbally, Cork. Hybrid: 3 days OnSite Purpose of the Role The Senior Process Engineer is a highly experienced technical authority responsible for end-to-end process ownership of assigned products manufactured at both Internal Sites and Contract Manufacturing Organisations (CMOs/CDMOs). The role provides deep engineering leadership from process selection and fit-to-plant assessment through technology transfer, scale-up, PPQ, commercial manufacture and lifecycle optimisation. The position safeguards product quality, process capability, regulatory compliance and continuity of supply by ensuring that external and internal manufacturing processes are scientifically understood, technically transferable, operationally robust and maintained in a validated state. The role is expected to operate independently in high-complexity situations, challenge technical assumptions, resolve difficult manufacturing problems, and influence decisions across internal functions and external partner organisations. Accountabilities Act as BioMarin’s senior technical authority for assigned externally and internally manufactured products, with accountability for the integrated body of process knowledge, scale-up rationale, critical variables, control strategy, validation status and known risks. Lead technical due diligence, process fit-to-plant and manufacturing feasibility assessments for new assets, new external partners, facility changes and product transfers. Translate findings into clear recommendations, residual risks, remediation plans, and investment requirements. Provide technical leadership for site selection, technology transfer, process scale-up, engineering runs, PPQ, launch readiness and commercial lifecycle management at CMOs/CDMOs. Maintain rigorous oversight of internal and external process performance through batch data review, statistical process monitoring, continued process verification, annual product review, and proactive identification of emerging signals. Own the technical response to complex deviations, recurring failures, yield loss, process excursions, validation concerns, and supply-critical events. Ensure conclusions are evidence-based, and CAPAs address the true failure mechanism. Ensure internal and external processes remain aligned with registered conditions, approved control strategies, quality agreements, validation commitments, and cGMP expectations. Represent the technical position in CMO governance, internal decision forums, audits, regulatory inspections and health authority interactions. Influence portfolio priorities, transfer strategy, network decisions and resource allocation through clear articulation of technical risk, product and patient impact, supply implications, cost and execution complexity. Key Responsibilities Manufacturing Technical Oversight Serve as the primary senior technical interface with assigned Internal/ CMOs/CDMOs and establish clear expectations for scientific rigor, engineering standards, data transparency, escalation and technical decision making. Provide on-site and remote oversight of manufacturing campaigns, key unit operations, technical investigations, validation activities, and major process changes. Assess external partner capability, equipment train, automation, utilities, raw material strategy, contamination controls and operational practices against product and process requirements. Integrate CMO data and observations with internal product knowledge to maintain a single, current and defensible technical understanding of the process. Identify supply and technical vulnerabilities early and drive practical mitigation, including additional studies, process controls, spares, alternate materials, capacity options or contingency plans. Technology Transfer and Process Fit-to-Plant Lead technology transfer planning and execution, including gap assessment, transfer scope, process description, knowledge transfer, facility and equipment fit, risk assessment, scale-up strategy, acceptance criteria and readiness governance. Perform detailed fit-to-plant assessments covering equipment geometry and capability, mixing, mass transfer, heat transfer, pressure and flow regimes, hold times, transfer paths, sampling, automation, cleaning, utilities, facility constraints and operator practices. Determine whether the receiving facility can reproduce the intended process and control strategy. Define adaptations using sound engineering principles while protecting product quality, comparability, and regulatory commitments. Lead scale-up and scale-down evaluations, engineering studies and process models needed to establish operating ranges and support transfer decisions. Author or approve of transfer plans, technical reports, process descriptions, risk assessments, gap closure plans, engineering run protocols, PPQ strategies and transfer completion reports. Chair technical readiness reviews and provide an evidence-based recommendation on readiness to proceed to engineering runs, PPQ and routine manufacture. Process Stewardship, Validation and Performance Maintain an integrated process description of linking unit operations, critical quality attributes, critical and key process parameters, material attributes, equipment interactions, control strategy and process risks. Own the process-specific risk register and ensure controls, monitoring plans, remediation actions and knowledge gaps remain current. Lead or approve PPQ and lifecycle validation strategies, protocols, reports, continued process verification plans and validation impact assessments. Apply statistical and engineering analysis to assess capability, variability, trends, shifts, correlations and sources of process noise. Lead periodic process performance reviews and identify priorities to improve robustness, yield, cycle time, capacity, reliability, right-first-time performance and cost without compromising compliance. Investigations, Change and Technical Problem Solving Lead or govern complex deviations, OOS/OOT events, contamination events, equipment-related failures and recurring performance issues at external sites. Use structured problem solving and first-p