Principal Process Engineer

This position of Principal Engineer, Process Development NPD is part of the Drug Products R&D Team within the Product Development Lifecycle Management and NPD Drug Product Organization. Based in Ireland, the Principal Engineer provides process-development leadership for new product development (NPD) supporting Vantive therapies.The role is the primary technical process development liaison between R&D and Manufacturing for assigned projects. The engineer develops manufacturing processes for validation and commercialization, coordinates the development of operating process parameters and drives disciplined execution of process development and process evaluation R&D activities at the receiving manufacturing plant. The role also supports engineering, manufacturing, quality and product development.

Key Responsibilities

Process initiation and process DevelopmentLead process-development planning and execution for NPD feasibility through production readiness.Translate product requirements and critical quality attributes into manufacturing-process requirements, operating parameters, validation, controls, and specifications.Plan process evaluation and development builds, process characterization, scale-up, and manufacturability assessments at manufacturing locations.Partner with the receiving plant to identify and close gaps related to process equipment, tooling, and process readiness.Support significant process and product changes where product material changes (chemical and container) impact existing validated processes.Provide process expertise for relevant manufacturing technologies and define practical, robust build methods in collaboration with Manufacturing and site Engineering.Drive equipment process readiness, necessary approved documentation, material availability, equipment validation readiness, data-collection, and closure of technical documentation to support process readiness.Manufacturing SupportThe Process Development Engineer will support process development activities for sustaining projects as required.The Process Development Engineer will support all activities in Castlebar as required by R&D leadership.Problem Solving and Technical InvestigationsLead or support investigations of issues arising during process evaluation R&D product builds, development processes, qualification and validation activities, and early production.Provide R&D technical support for process issues, product defects relating to process issues, and process-related issues observed on pre commercial production equipment.Use structured, data-based problem solving to assess interactions among product design, materials, equipment, tooling, process parameters, methods, and environmental conditions.Define, evaluate, and verify corrective actions and risk mitigations without compromising product quality, safety, performance, or compliance.Document investigation rationale, evidence, conclusions, and recommendations in accordance with Good Documentation Practices.Quality, Risk Management and DocumentationPerform assigned activities in accordance with applicable quality systems, design controls, risk-management requirements, Good Documentation Practices, cGxP expectations, and relevant standards.Support change control, nonconformance, CAPA, product-impact assessment, regulatory, audit, and inspection activities when R&D process expertise is required.Qualifications & ExperienceEducationBachelor's or master's degree in Bulk Chemical Solutions Process Engineering, Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Pharmaceutical Engineering, or a related discipline. A master's degree is preferred.Critical Experience & SkillsMinimum 7 years of relevant industrial experience in R&D process development, manufacturing engineering, Chemical drug solution products manufacturing, or sustaining products engineering in a regulated industry.Demonstrated experience in design, developing and implementing manufacturing processes for new products or significant product changes.Experience transferring products and process knowledge from R&D to Manufacturing or Site to site manufacturing and supporting engineering builds, qualification, validation, and process launch readiness.Strong problem-solving experience involving product design, materials, equipment, tooling, process parameters, or production-line issues.Experience planning NPD process builds, coordinating sample testing, interpreting technical data, and identifying risk mitigations.Working knowledge of design controls, risk management, change control, process validation, and technical documentation.Ability to work effectively across R&D and Manufacturing engineering, manage priorities, communicate clearly, and drive assigned actions to completion.Preferred ExperienceExperience in pharmaceutical drug solutions manufacturing, medical device products manufacturing, combination-product, or another highly regulated product environment.Knowledge of one or more relevant manufacturing technologies, such as pharmaceutical drug solutions manufacturing, polymer extrusion, molding, welding, forming, assembly, bag making, filling, packaging, or automated inspection.Familiarity with process characterization, design of experiments, statistical analysis, process capability, equipment qualification, and applicable FDA, EU, ISO, ICH, or cGxP expectations.TravelTo be discussed. Travel may include visits to receiving manufacturing plants, suppliers, laboratories, and other R&D locations, is expected.