Validation Engineer

This is an initial 12-month contract to support the introduction of a new clean-line system.

This role can offer an immediate start in an excellent organisation with a great team.

Suitable for someone with at least 2 years experience.

Please reach out today for more details 022 46969 and [email protected]

Role

• Excellent organization, relationship building and influencing skills.
• Responsible for ensuring conformance with current equipment, process, and systems validation regulations.
• Management of the Asset Lifecycle for new equipment and processes (URS/RA/IQ/OQ/PQ).
• Assist in PFMEA studies and risk assessment effort for overall process.
• Project planning to deliver project(s) against agreed milestones and project scope (schedule, resource, cost).
• Knowledge of statistical analysis software (e.g. MATLAB) and manufacturing processes.
• Develop manufacturing process instructions and inspection specifications.
• Provide Training and Work instructions for production operators and inspectors.
• Carry out the validation of equipment and processes.
• Ensure adherence to regulatory requirements, ISO & FDA. Skills and

Education Requirements: Education & Experience

• Obtained as a minimum a Degree in Mechanical/Production/Manufacturing Engineering and 3 years minimum postgraduate (Ideally 5 years plus) experience in a medical device or comparable hi-tech environment.
• Cleanline validation experience desirable.
• Proven problem solving and hands on approach.
• A confident self–starter with the ability to work on their own initiative or as part of a team. Technical skills:
• Proficient in the use of validation software packages and Minitab would be an advantage.
• Proficient in the use of drawing software(SolidWorks) for developing fixtures and drawings for new Cleanline, would be desirable but not essential.