- BBBH769398 Dec 22, 2020 Competitive
This is an excellent opportunity to join a successful and well-established on site team, while having ownership of your own projects
I am delighted to bring this opportunity to market for any Experienced Validation engineers who are looking for a new permanent opportunity. If you are looking for a role where you can join a successful and well-established on site team, while having ownership of your own projects then this may be the role for you.
This role is with a growing Global manufacturer of Medical devices in Cork and will be supporting the validation, change management, in process monitoring and maintenance of the special processes utilised on site as well as all other equipment validation work completed. Particular focus will be placed on the Critical In Process and Final Cleaning processes.
A bit more about the role:
- Review and execution of process validations related to special processes ensuring compliance to all internal requirements as well as FDA and ISO regulations.
- Generation, review and approval of validation documentation related to all other new equipment.
- Identify and implement cost saving initiatives related to the validation process.
- Develop and implement comprehensive test plans as well as test methods to ensure that special processes are robust and remain within the validated state.
- Establish and track manufacturing requests relative to testing sample requirements
- Be the Quality Engineering Operations point of contact for production when risk assessing or troubleshooting new and existing issues related to the special processes whether that involve design, materials or equipment, and provide creative, timely, and cost-effective solutions.
- Support Quality for non-conformities and CAPA relatives to special processes (investigation; impact assessment, action plans)
- Represent Quality Engineering Operations on validation related projects, give guidance on approach taken and establish associated reporting,
- Review, approval and/or execution of the Change Control process when required.
- Support QA and RA groups during audits, inspections and authorities responding when related to special processes and especially Critical In Process and Final Cleaning processes.
Skills, Education and Experience Requirements:
- Strong Interpersonal communication and decision making skills
- Problem solving ability & effective time management skills
- Ability to present planning and prioritization for results using Microsoft project or equivalent
- Minimum Level 7 Degree level qualifications in a related technical discipline.
- Minimum of 5 years' experience working in a similar engineering role and/or have equivalent process validation experience.
- Technical knowledge on Critical Cleaning processes and the execution of ISO 19227 and related requirements.
- Knowledge of medical device cGMP, European & US regulations desirable.
- Lean and Six Sigma qualifications are an advantage.
If you are interested in this role, or if you would like to find out more click on the 'apply now' button below or get in touch with Kellie today on 021 2300 300 or firstname.lastname@example.org
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
Senior Consultant | Engineering Recruitment - Quality & Validation
353 (0) 21 2300300