During the project the Validation Engineer will:
-Autoclave load qualification, Depyrogenation tunnel qualification and SIP qualification (including Lyophilisers & vessels) in support of a new product introductions as well as process the qualification of CTC's across the site to support ongoing projects.
-Development of Validation Plans, Cycle Development, Performance Qualifications, Requalification Protocols and System Summary reports for Autoclaves, Steam in Place Systems and Controlled Temperature Chambers (CTCs).
-Preparing, executing, documenting and reporting validation protocols in line with GMP’s and other regulatory requirements and standards.
-Assuring that all validation test procedures are in line with current technology, corporate and governmental regulations.
-Ensuring that the site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards.
-Reviewing and approving validation protocols and assessments from a quality system documentation perspective.
-Assisting in deviation, exception resolution and root cause analysis.
-Participating as required in project activities.
To be considered for the role you should have the following skills, knowledge and experience:
-Bachelor of Science/Engineering degree or equivalent.
-Knowledge of cGMP’s and other worldwide regulatory requirements.
-Problem solving ability and excellent oral and written communications skills
-Knowledge of the use of Biological indicators and Thermal Mapping to demonstrate system sterility/temperature control
-Hands-on experience with temperature mapping equipment, eg Ellab, LIVEs or equivalent
-Bio tech/Pharma background
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference TC41458 in all correspondence.