Job Title: Process Development Engineer
Contractor Role
Onsite
Location: Galway, Ireland
Purpose Statement:
The Process Development Engineer will collaborate closely with R&D and Manufacturing teams to develop robust, cost-effective, and safe manufacturing processes, equipment, and materials.
This role ensures the efficient transfer of new products and processes into commercial production.
Key Responsibilities:
Technical Expertise:
Provides strong technical leadership in process and product technologies, supporting the selection, design, optimisation, validation, and troubleshooting of these technologies.
Mentors engineers and technicians in problem-solving and technical resolutions.
Collaboration with Vendors:
Works closely with Equipment Engineering and external vendors to select, design, and develop new equipment, tooling, and materials, or upgrade existing ones.
Application of DFSS/DMAIC Tools:
Utilises extensive knowledge of DFSS/DMAIC tools to characterise, optimise, and troubleshoot process equipment and technology performance.
Experimentation and Testing:
Leads the planning and execution of experiments and testing to characterise, optimise, and troubleshoot key processes and equipment.
Summarises, analyses, and draws actionable conclusions from test results to achieve effective technical solutions.
Process Introduction and Documentation:
Coordinates the introduction of new processes, equipment, and materials, including installation, calibration, EHS assessments, debugging, and all necessary process and quality system documentation.
Demonstrates expertise in Lean methodologies and process improvement tools to identify and eliminate waste, enhancing process efficiency and cost-effectiveness.
Validation and Compliance:
Applies strong knowledge of process and equipment validation techniques, PFMEA, and regulatory requirements to ensure timely and efficient validation of equipment and processes.
Leads the preparation and release of process validation documentation, including FMEAs, Validation Plans, protocols, and reports, with proficiency in IQ, OQ, PQ, and TMV.
Project Coordination:
Oversees validation builds, coordinates the testing of validation units, and manages the compilation, analysis, and reporting of validation results.
Supervision and Development:
Supervises one or more technicians, managing their technical development and supporting their daily tasks and project work.
Commitment to Quality and Safety:
Demonstrates an unwavering commitment to patient safety and product quality, ensuring compliance with all regulations governing quality systems.
Ensures that all direct reports understand their responsibilities regarding patient safety and product quality, are up-to-date with training, and comply with relevant regulations.
Quality System Requirements:
In all actions, upholds a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.
Supervisory Responsibilities:
Ensures that appropriate resources (personnel, tools, etc.) are maintained to ensure Quality System compliance and adherence to the company's Quality Policy.
Fosters a work environment that supports the Quality Policy and Quality System.
Job Scope and Levelling Guidelines:
Functional Knowledge:
Requires advanced conceptual and technical knowledge in the relevant job function.
Broadens capabilities in applying job-related concepts.
Business Expertise:
Demonstrates a strong understanding of industry practices and company processes to achieve objectives.
Leadership:
No direct supervisory responsibilities but is accountable for personal contributions and meeting project objectives.
Problem Solving:
Uses sound judgment to solve problems in straightforward situations and determines the best course of action.
Operates under general direction from senior-level roles or a manager.
Impact:
Influences the quality of personal work and the work of others on the team, adhering to established guidelines and policies.
Interactions and Communications:
Clearly explains factual information to others in straightforward situations.
Organises, presents, and explains data/information primarily to internal audiences.
Qualifications:
Minimum Level 8 Engineering degree, with a strong preference for candidates qualified in Mechatronics and with SolidWorks experie
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