JOB PURPOSE
As a member of the Quality team, the Validation Engineer / Validation Facilitator will manage and develop the Validations within the Quality Management System to ensure that plant goals and objectives are achieved, and both product and process meet specifications & acceptance criteria, statutory obligations and customer requirements.
RESPONSIBILITIES
Perform a key role in the planning, execution and closure of process validations and/or trial activities within a high-volume medical device injection moulding / automation environment.
Interpret customer specifications and translate into an MGS validation master plan.
Coordinate cross functional meetings to ensure validation plan is successful and provide metrics on same
Coordinate the measurement and inspection of all validation and/or trial samples according to approved protocols and SOPs.
Analyse and interpret data and provide timely and accurate feedback to all relevant stakeholders in the validation process.
Assist in the preparation of reports and protocols as required.
Ensure all paperwork is completed, GDP compliant and located/filed in the appropriate location.
Maintain and own the Validation procedures and forms in the QMS.
Maintain best practice validation templates.
Correct storage of validation samples and maintenance of validation sample area.
Assist Metrology Engineer on MSA/Gauge R&R.
Pro-actively ensure GMP, EHS and housekeeping standards, etc., are maintained.
Assist and support all continuous improvement activities to include but not limited to GMP, GDP, etc.
Respond to customer queries relating to specifications and quality issues on validation activities
Proactively engage in continuous professional development.
QUALIFICATIONS
Have relevant academic qualifications (e.g., Quality Assurance, Engineering, etc.), and previous relevant work experience in a high-volume, GMP compliant manufacturing environment;
Possess excellent verbal and written communication skills, to include Technical Report Writing;
Have strong information management skills to include experience of using statistical techniques for data analysis;
Have excellent organisational skills and the ability to multi-task in a fast-paced, dynamic environment in order to meet deadlines;
Be able to analyse and present data to a high degree of accuracy – SPC Knowledge preferrable;
Be proficient in MS Office and standard laboratory information management systems;
Be a team player and capable of working independently and on own initiative.
EDUCATION AND EXPERIENCE
The ideal candidate will be able to work on a day-shift basis with occasions need for over time, and will:
This role is ideal for a qualified candidate with some experience in the engineering or medical device field who wishes to further develop their knowledge and experience. The candidate will gain invaluable experience in the following areas: medical device manufacture; medical device moulding and automation process validation; validation protocol generation and execution; metrology principles; sampling plans; statistical process control; data analysis and presentation. The candidate will interact heavily with the following: Laboratory Operator, Project Manager, Quality Engineer, Process Engineer, Metrology Engineer, Production Manager and Operations Manager.
MGS is an equal opportunities employer
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