The Validation Engineer will have responsibility for writing validation protocols, executing protocols and writing validation
Reporting to: Senior Technical Programme Manager
To work under the direct supervision of the department manager
Generation and completion of validation documentation (protocols and reports) and execute of qualifications such as IQ/OQ/PQ.
Recording and analysis of process data including use of statistical process control techniques.
Ensure all data and results are accurately reported and follow up on any gaps or discrepancies
Review of vendor prepared/executed commissioning & validation documentation
Generation of product and process risk assessments per ISO14971
Reporting of Validation non-conformances and providing solutions to remediate issues
To ensure that good GMP/QMS standards are maintained at all times.
To maintain accurate and neat records of all results generated
To assist in the review and generation of SOP’s
To ensure that all materials required for use are ordered
Carrying out non- routine testing as requested by the department Manager
Ensure compliance with current GMP and the company quality system for all areas
To be responsible for the protection and well-being of other company personnel.
Understand the Company’s Health & Safety Policy and follow all Company procedures.
Report all accidents or any unsafe conditions in the work-place that they are aware of to Management and also maintain in a good state of repair all protective clothing and equipment.
Support both management and the workforce in their charge with the implementation of Health and Safety arrangements and procedures in their work activities. Also required to set by personal example high standards of operation to ensure risk-free operation of progress, equipment and procedures and communicate effectively with both management and staff so that the following principal duties are carried out:
Safety rules are understood and followed
Main hazards associated with their work activities are identified and risks controlled
Near-miss reporting procedures are followed and management is notified of any safety concerns as soon as practicable
Maintain high standards of housekeeping and cleanliness at all times
Advise management on improvements to existing working practices so that risks can be eliminated, and overall process and safety performance can be improved
Comply with the environmental management system and minimise environmental impact where possible.
Ensure training has been received in relation to specific duties and that all training is documented in training records
To assist in the training of new or less experienced staff
Responsible for ensuring that the Company’s Absence Control Policy and Procedure is consistently applied to within their area of control
Conform to the Company’s Absence Policy and to adhere to Absence Procedures
Report any out-of-specification results to their direct Line Manager
- Minimum of degree in a Science or Engineering related discipline or equivalent experience of at least 3 years with minimum HNC / HND
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