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| Job Location | Bridgend |
| Education | Not Mentioned |
| Salary | 40,000 - 45,000 per annum, negotiable |
| Industry | Not Mentioned |
| Functional Area | Not Mentioned |
| Job Type | Permanent , full-time |
Jennifer Griffiths Recruitment are looking for an experienced Project Engineer for a Client in the Bridgend area.Key Responsibilities* Design and development of complex electro mechanical products for use in regulated environments.* Daily Engineering activities and supporting of key business functions.* Determination of user needs and product requirement specifications.* Liaising with internal stakeholders, external clients, suppliers and consultants.* Preparation of technical documents such as component specifications, risk management reports and technical reports for incorporation into product technical files.* Define and manage strategies to evaluate performance of development parts, assemblies, or systems under simulated operating conditions.* Provide technical assistance and resolution when engineering problems are encountered before, during and after construction culminating in successful Factory Acceptance Tests.Experience and SkillsEssential* A minimum of five years postgraduate industrial experience in the design and development of electrical, electronic, or electro-mechanical products.* Experience of working in a highly regulated industry, within pharmaceutical or medical devices ideally.* A logical and pragmatic approach to the product development process including the solution of technical problems with a capacity for original thinking.* The ability to work alone and unsupervised or as part of a closely integrated project team.* Technical competency both analytical and practical.Desired* Working knowledge in EU GMP Annex 11, GAMP 5 and associated computerised system validation within the pharmaceutical environment.* Working knowledge in EU GMP Annex 15 for process validation.* Writing User Requirement Specifications, Design/Installation/Operational/Performance Qualification protocols and reports for validation and/or trial purposes.The hours of work are: Flexible between 8am and 5pm, Monday to Friday, 37.5 hours a week.Holidays: 25 days plus bank holidays.
Keyskills :
Electrical EngineeringElectrical InstallationGMPMedical DevicesGAMP