Senior Process Engineer

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 EngineerCommerical Support, Technical DevelopmentLocation: 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-principles engineering to distinguish fact from hypothesis, test failure mechanisms and establish scientifically defensible root cause.
• Assess technical feasibility, comparability, validation impact and regulatory risk for CMO-initiated and internal changes to process, equipment, facility, automation, materials, suppliers, methods or scale.
• Challenge incomplete data packages, weak scientific rationale or unjustified residual risk, and ensure corrective actions are measurable and effectiveness checked.
• Provide rapid, calm and authoritative technical leadership during supply-critical or high-severity events.
• Ensure consistency between routine manufacturing practice, process knowledge, validation evidence, regulatory filings and post-approval commitments.
• Provide technical content and review for submissions, variations, comparability packages, responses to health authority questions and inspection preparation.
• Support CMO and internal audits and inspections as the process technical representative, presenting clear, traceable and scientifically defensible evidence.
• Work in close partnership with Quality while retaining independent technical judgement and clear ownership of engineering and process conclusions.
• Lead complex cross-functional teams spanning Technical Development, Manufacturing, Quality, Regulatory, Engineering, Supply Chain, Procurement and external partners.
• Mentor engineers and scientists in technology transfer, scale-up, process analysis, investigations and risk-based decision making.
• Build productive CMO and internal relationships while maintaining appropriate technical challenge, accountability and escalation.
• Communicate complex technical matters clearly to senior leaders, governance bodies, inspectors and multidisciplinary audiences.

Education and Professional Experience

• Bachelor’s degree or higher in Chemical Engineering, Biochemical Engineering, Biotechnology, Pharmaceutical Engineering or a closely related technical discipline. A Master’s degree or PhD is advantageous where it strengthens the specialist’s contribution.
• 15+ years of progressive experience in biopharmaceutical or pharmaceutical process engineering, technical operations, process development, manufacturing science or an equivalent highly regulated technical environment.
• Extensive direct experience providing technical oversight to external manufacturing partners, including CMO/CDMO governance, on-site campaign support, technical escalation, and performance management.
• Demonstrated leadership of multiple technology transfers across sites or organisations, from initial assessment and knowledge transfer through engineering runs, PPQ, launch and commercial handover.
• Deep hands-on experience in process fit-to-plant assessment, equipment and facility gap analysis, scale-up, process adaptation and transfer risk management.
• Advanced practical experience with commercial biologics manufacturing. Experience across upstream and downstream processing, drug substance operations and associated unit operations is strongly preferred.
• Proven success leading complex investigations, process validation and PPQ, lifecycle changes, comparability assessments, process optimisation and supply-risk remediation.
• Strong working knowledge of global cGMP expectations, ICH guidance, process validation of lifecycle principles, data integrity, and regulatory inspection support.
• Demonstrated capability in statistical process monitoring, multivariate or advanced data analysis, process capability assessment, and structured problem-solving methods including FMEA, RCA, CAPA, and Lean Six Sigma.
• Experience influencing decisions without direct authority and operating effectively across organisational, geographic and cultural boundaries.
• Willingness and ability to travel to external manufacturing sites, including during critical transfer, validation, or issue-resolution activities.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Ireland Safety Responsibility Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.
Ireland Safety Responsibility
Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.