Lead Process Development Engineer, NPD (Drug Products)

Vantive; Castlebar; On-site; EUR 110,000 - 140,000; Full time

Job summary

Vantive, based in Ireland, seeks a Principal Engineer, Process Development NPD (Drug Products) to lead process development for new therapies and act as the primary technical liaison between R&D and Manufacturing for assigned projects.

The role focuses on translating product requirements into manufacturing-process specs, planning scale-up and validation, and ensuring readiness for production while collaborating with engineering, quality, and product development teams.

Qualifications

• Bachelor's or master's degree in Bulk Chemical Solutions Process Engineering, Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Pharmaceutical Engineering, or a related discipline.
• Minimum 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.
• 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.

Responsibilities

• Lead 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.
• The 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.
• Lead 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.
• Perform 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.

Skills

Problem solving

Cross functional collaboration

Process development

Manufacturing transfer

Data analysis

Communication

Education

Bulk Chemical Solutions Process Engineering

Mechanical Engineering

Manufacturing Engineering

Biomedical Engineering

Pharmaceutical Engineering

Job description

Vantive, based in Ireland, seeks a Principal Engineer, Process Development NPD (Drug Products) to lead process development for new therapies and act as the primary technical liaison between R&D and Manufacturing for assigned projects.

The role focuses on translating product requirements into manufacturing-process specs, planning scale-up and validation, and ensuring readiness for production while collaborating with engineering, quality, and product development teams.