Quality / Validation Engineer - Pharmaceutical Manufacturing

Job Description

Our Client is a very successful pharmaceutical manufacturing company. They are now seeking a Quality Engineer. This position is a full-time permanent role and will be based in Great Yarmouth.Job PurposeAn exciting opportunity has arisen for a Quality Engineer to join a highly successful and dynamic Pharmaceutical Manufacturing site in Great Yarmouth. Working as part of a professional team within a clean manufacturing environment where the highest qualitystandards are observed, you will be responsible for the completion / coordination of engineering quality documentationKey Areas of Responsibility

• Support the site validation strategy across various engineering projects including facilities, equipment, processes, and services
• Work with the technical and operational teams to ensure the site validation system is established and maintained in accordance with internal procedures, regulatory requirements and industry guidance / standards
• Working collaboratively with all departments, produce and execute validation protocols, and develop equipment validation/qualification requirements (DQ, IQ, OQ, PQ)
• Coordinate directly with vendors and service providers to ensure that all validation and installation requirements are being satisfied during the execution of protocols
• Develop timelines for all projects and ensure that deadlines and goals are being met. Provide frequent updates to management and team on progress.
• Provides resource and expertise in the management of change controls relating to engineering projects
• Assists in the investigation and close out of Deviations/Non-Conformities including the definition and actioning of CAPAs
• Assist in the completion of risk assessments, FMEA and Root Cause Analysis
• Support continuous improvement projects relating to both sustaining engineering and product development activities
• Maintain an awareness of regulatory and industry best practice trends, hot topics and changes in relation to engineering activities and communicate to the team

Qualifications / Experience

• The ideal candidate will bring previous experience of validation processes, change control and risk management, ideally gained within the Pharmaceutical or Medical Device industry
• It is anticipated that academic qualifications will be in the field of Science, Engineering or Manufacturing Technology
• Education will be supported by work-based experience in a similar role
• The candidate should also offer knowledge of cGMP and / or ISO13485, ISO9001 and Lean Six Sigma
• Excellent verbal & written communication skills with the ability to present complex issues in a clear, logical and persuasive way
• Strong organisational skills, with the ability to handle a broad range of responsibilities and multiple priorities and projects
• Excellent internal and external relationship management skills
• Enthusiastic in the pursuit of engineering and production quality and performance perfection
• A proven track record of problem solving and decision making with proactive identification of improvements
• Strong project management skills, delivering results on time and in budget
• Ability to work collaboratively and influence cross-functional teams

In return our client is offering a competitive salary and benefits package for the successful CandidatePlease send your C.V to Lorraine Roger, Director at Atom Recruitment Ltd.

Keyskills :
EngineeringISOPharmaceuticalValidationQuality