Principal Engineer - Process Development NPD (Drug Products)

Company Overview

Vantive is dedicated to advancing vital organ therapies, with a legacy of 70 years focused on kidney care innovations. The company aims to enhance the dialysis experience through digital and advanced services, seeking to improve therapy administration flexibility and efficiency for care teams and deliver longer, richer lives for patients worldwide.

Role Summary

The Principal Engineer in Process Development is a key member of the Drug Products R&D Team in Ireland, responsible for leading process development for new product development (NPD) initiatives supporting Vantive therapies. Acting as the main technical bridge between R&D and Manufacturing, this role drives development, validation, and commercialization of manufacturing processes while collaborating closely with engineering, manufacturing, quality, and product teams.

Key Responsibilities

• Lead planning and execution of process development from feasibility to production readiness for new products.
• Convert product requirements and quality attributes into manufacturing process specifications and controls.
• Oversee process characterization, scale-up, manufacturability assessments, and builds at manufacturing sites.
• Collaborate with manufacturing plants to resolve equipment, tooling, and readiness issues.
• Support major process and product changes affecting validated manufacturing processes.
• Provide expertise in manufacturing technologies and define robust build methods with cross-functional teams.
• Ensure equipment process readiness, documentation, validation, and data collection to support process implementation.
• Assist with process development activities related to sustaining projects and other R&D needs in Castlebar.
• Lead or support investigations relating to process issues arising during R&D product builds, qualification, validation, and early production phases.
• Apply structured, data-driven problem solving to address complex process and product design challenges.
• Define and verify corrective actions and risk mitigations without compromising quality or compliance.
• Maintain thorough documentation compliant with Good Documentation Practices.
• Comply with quality systems, design controls, risk management, cGxP, and relevant regulatory standards.
• Support quality and regulatory activities such as change control, CAPA, audits, and inspections as required.

Qualifications and Experience

• Bachelor's or preferably master's degree in Bulk Chemical Solutions Process Engineering, Mechanical, Manufacturing, Biomedical, Pharmaceutical Engineering or related discipline.
• At least 7 years' industrial experience in R&D process development, manufacturing engineering, or sustaining engineering within regulated industries.
• Proven track record designing and implementing manufacturing processes for new or significantly changed products.
• Experience transferring process knowledge and supporting builds, qualifications, validations, and launches in a manufacturing context.
• Strong problem-solving skills related to product design, materials, equipment, tooling, and process parameters.
• Competence in planning NPD builds, testing coordination, data interpretation, and risk mitigation strategies.
• Working knowledge of design controls, risk management, change control, process validation, and technical documentation.
• Excellent communication, priority management, and cross-functional collaboration skills.

Preferred Experience

• Pharmaceutical drug solutions manufacturing, medical devices, combination products, or similar highly regulated environments.
• Familiarity with manufacturing technologies such as polymer extrusion, molding, welding, assembly, packaging, filling, and automated inspection.
• Understanding of process characterization, design of experiments, statistical analysis, equipment qualification, and relevant FDA, EU, ISO, ICH, or cGxP standards.

Additional Information

• Typical business travel of approximately 20%, including visits to manufacturing plants, suppliers, laboratories, and other R&D sites.
• Vantive supports reasonable accommodations for applicants with disabilities throughout the recruitment process.
• Awareness required about recruitment fraud and how to identify legitimate communication from the company.