Job description

Title: Engineer I, Process

Location: Ireland - Galway

Function: Process Development

Level: Professional - Level 1

Purpose Statement

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.

Quality System RequirementsIn all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.For those individuals that supervise others, the following statements are applicable:

• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Clients Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

Management Requirements

• Not applicable.

Job Scope and Leveling Guidelines

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.

Job Type: Full-time

Salary: €45,000.00-€60,000.00 per year

Schedule:

• Day shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Galway, County Galway: reliably commute or plan to relocate before starting work (required)

seankuhnke.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, seankuhnke.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, seankuhnke.com is the ideal place to find your next job.