Process Development Engineer
Contracting role
Galway

Works closely with R&D and Manufacturing in the development of robust, capable, cost effective & safe manufacturing processes. equipment, materials and products and supports efficient and effective transfer of new products & processes into commercial production.

Key Responsibilities

• Demonstrates strong technical expertise on process/product technologies to support selection, design, optimisation, validation and troubleshooting of, and can mentor engineers and technicians in problem resolution on, those technologies.
• Liases with Equipment Engineering or external equipment/tooling or material vendors in the selection, design & development of new (or upgrades to existing) equipment, tooling and materials.
• Demonstrates strong knowledge of DFSS/DMAIC tools and applies these tools in the characterization, optimization and troubleshoooting of process equipment and technology performance.
• Leads the development and execution of experimentation and testing to enable characterisation, optimization and troubleshooting of key processes and equipment. and summarises, analyses and draws conclusions from test results leading to effective technical resolution.
• Co-ordinates the introduction of new processes, equipment and materials including installation, calibration, EHS assessment debug, and all associated process and quality system documentation requirements including technical and process work instructions.
• Demonstrates strong knowledge and application of Lean methodologies, and process improvement tools in identification and elimination of "waste" process steps and development of efficient, cost effective equipment and processes.
• Demonstrates strong knowledge and application of Process and equipment validation techniques, PFMEA’s, and associated regulatory requirements and applies this knowledge in the efficient & timely validation of equipment and processes.
• Completes or leads the writing and release of process validation documentation including FMEA's, Validation Plans, protocols and reports.
• Co-ordinates execution and documentation of validation builds, co-ordinates testing of validation units and the compilation, analysis and reporting of the validation results.
• Supervision of one or more Technicians, managing their technical development and facilitating their daily and project tasks.
• Demonstrates a primary commitment to patient safety and product quality.
• Ensures all direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.
• Understands and complies with all the regulations governing the quality systems.

Knowledge

A developing professional. Working knowledge and application of business and technical concepts, procedures and practices. General knowledge of industry practices, techniques, and standards. General understanding of business unit/group function. Exercises judgment when interpreting company policies and procedures to resolve a variety of issues.

Problem Solving

Develops solutions to a variety of problems of moderate scope and complexity where analysis of situations or data requires a review of identifiable factors. Exercises judgment to determine appropriate action. Has knowledge of alternatives and an understanding of their impact on the business or technological environment.

Planning and Organization

Plans, organizes, and prioritizes own daily work routine to meet established schedule.

Discretion/Latitude; Supervision Received; Decision Making

Works under general direction regarding the progress of projects and special assignments. May seek guidance in resolving problems, interpretating established policies, procedures and practices. Work is reviewed for soundness of judgment.

Business Relationships and Project Management

Cultivates a wide range of internal business relationships and begins to develop an external network of resources to facilitate completion of tasks. May lead a project team of small to moderate scope. Influence exerted at peer level and occasionally at first levels of management.

Impact

Contributes to the completion of departmental projects and goals. Errors in judgment, poor recommendations, or failure to achieve results would normally require a moderate expenditure of resources to rectify.

Liaison

Engages with internal company and external contacts. Represents organization on specific projects. Uses diplomacy and tact in interactions and problem solving.

Mentoring

Provides guidance to less experienced staff.