Senior Process Development Engineer, NPD (Drug Products)

Vantive; Castlebar Municipal District (2014-2019); On-site; EUR 110,000 - 150,000; Full time

Job summary

Vantive is seeking a Principal Engineer, Process Development NPD (Drug Products) based in Ireland to lead new product development process development for NPD therapies. This role acts as the primary technical liaison between R&D and Manufacturing to develop manufacturing processes for validation and commercialization.

You will drive process readiness at receiving plants, coordinate parameters, and support engineering, quality and product development.

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. A master's degree is preferred.
• 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.

Skills

Process development

R&D to Manufacturing transfer

Problem solving

Cross-functional collaboration

Regulated industry experience

DOE / statistics knowledge

Education

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

Tools

Process validation

Statistical analysis / DOE

Job description

Vantive is seeking a Principal Engineer, Process Development NPD (Drug Products) based in Ireland to lead new product development process development for NPD therapies. This role acts as the primary technical liaison between R&D and Manufacturing to develop manufacturing processes for validation and commercialization.

You will drive process readiness at receiving plants, coordinate parameters, and support engineering, quality and product development.