Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Principal Engineer, Process Development NPD (Drug Products)

Ireland | Drug Products R&D

Your Role:

This position 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 Development

• 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.
  

Manufacturing Support

• 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.
  

Problem Solving and Technical Investigations

• 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.
  

Quality, Risk Management and Documentation

• 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.
  

Qualifications & Experience

Education

• Bachelor'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 & Skills

• 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.
• 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 Experience

• Experience 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.
  

Travel

• Approximately 20% business travel, including travel to receiving manufacturing plants, suppliers, laboratories, and other R&D locations, is expected.

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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