- Our client is looking for a Project Engineer to join their busy site in Co. Waterford.
- The Project Engineer will participate in process validation activities, writing protocols, data gathering and analysis, validation report generation.
- The successful candidate will analyse data and trends, correlations, etc to better understand process interdependencies and demonstrate the process is capable as alternative sources are introduced into a process.
- The candidate will be interfacing with an internal cross functional team while working on these validation programs.
Core Duties and Responsibilities:
- Develop Quality Change Requests (QCR’s) to introduce and validate new raw materials into existing processes.
- Plan and coordinate assigned engineering projects including requesting line time for development protocol and validation executions.
- Gather stakeholder input to write protocols with clearly defined acceptance criteria.
- Design, develop, conduct and/or review experiments to introduce alternate raw material sources while maintaining product safety.
- Conduct and support process validations.
- Generate engineering development and validation reports for new raw materials.
- Identify through the validation process and through in process monitoring and trending, opportunities for process/productivity improvement and optimisation.
- Support new and existing manufacturing processes, quality improvements and cost reductions.
- Support drafting new or update existing documentation such as WIs, SOPs, pFMEA’s for process changes being introduced through validations.
- Ensure product quality and all tasks are in accordance with established SOPs, GMPs, Divisional Specifications, and EHS standards.
- Develop, design and train manufacturing personnel in required operations.
- Deliver project requirements to agreed cost, schedule, and quality requirements.
- Completing engineering analysis and support implementing necessary corrective actions to resolve problems.
- Work collaboratively with others such as Supplier Quality, Procurement QC etc. to accomplish goals.
- Support the Company Programmes and culture within the Company.
Minimum Qualifications and Experience:
- Education: Level 8 degree in a science or engineering discipline.
- Experience: 1-5 years engineering experience in a high-volume manufacturing environment; Analytical Process / Product Development or Quality Engineering setting. Hands-on technical experience in protocol execution. ISO-9000, GMP, medical device manufacturing experience a plus. Statistical analysis required within a development or manufacturing setting. Experience with high volume and / or high precision manufacturing a plus.
- Experience in writing and executing validation protocols in a high-volume manufacturing environment.
- Experience in collaborating with other departments in setting validation acceptance criteria, along with execution of validations and report generation.
- Special Skills: Computer Literacy with skills in Microsoft Excel, Word, PowerPoint, plus MiniTab (or equivalent software). Operational knowledge of statistical techniques.
- Communication, Organisation, Report Writing, and Presentation skills desirable.
- Must be able to develop working relationships with various internal core competencies and work as a team member.
- Good negotiation and influencing skills.
- Problem solving skills.
To Apply: Quote – PE23091
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100
Please note, we do not require agency assistance with this role.