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Validation Engineer
- Posted 15 April 2024
- Salary Negotiable
- LocationWaterford
- Job type Temporary
- Discipline Manufacturing
- ReferenceEMcS3
- Contact NameElaine McCarthy
Job description
About the Company
A renowned Global company is looking for a Validation Engineer to join their Waterford site on a fixed term contract. The Engineer will be leading the validation area while engaging in process validation activities, writing protocol and validation report generation.
About your new job
- Develop Quality Change Requests (QCR’s) to introduce and validate new raw materials into existing processes.
- Organize and manage engineering projects, including scheduling time for development and validation tasks.
- Collect input from stakeholders to write protocols with clear acceptance criteria.
- Design, develop, conduct and/or review experiments to introduce alternate raw material sources while maintaining product safety.
- Conduct and support process validations.
- Carry out and assist in process validations.
- Produce reports on engineering development and validation for new materials.
- Identify through the validation process and through in process monitoring and trending, opportunities for process/productivity improvement and optimisation.
- Assist in enhancing manufacturing processes, quality, and cost efficiency.
- Support drafting new or update existing documentation such as work instructions, 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.
- Perform engineering analysis and implement corrective actions when issues arise.
- Collaborate with others such as Supplier Quality, Procurement to accomplish goals.
- Support the company initiatives and culture within the Company.
What skill/experience you need
- Bachelor’s degree in Science or Engineering required.
- 1+ engineering experience in high-volume manufacturing environment; Analytical Process/Product Development or Quality Engineering setting.
- Knowledge of ISO-9000,GMP, and medical device manufacturing is advantageous.
- High Volume Manufacturing experience is essential.
- Statistical analysis experience is necessary in high-volume manufacturing setting.
- Proficiency in writing and executing validation protocols in manufacturing.
- Ability to collaborate with other departments to set validation acceptance criteria, execute validations, and generate reports.
- Statistical techniques knowledge essential
- Must be able to build relationships with various internal teams and work effectively as a team member.
What’s on offer
- Fixed Term 12 Month Contract
- Excellent Rate DOE
- 24 days Annual leave
- Monday-Friday
What’s next
- Apply now by clicking “Apply Now” or contact me at 021 484 7135
- Or if the job isn’t quite right but you are looking for something similar, please get in touch.