Description
Position Description and Responsibilities:- To provide support for cleaning validation activities ensuring that all compliance issues and requirements of Validation Policies and Procedures are addressed.
- Review and approve Validation Master Plans, Protocols, Summary Reports and other documentation associated with cleaning validations.
- Ensure all cleaning validation activities and documents are authorised and appropriate compliance approval is gained.
- Ensure that all cleaning validation activities are carried out and reported in a timely manner.
- Ensure compliance through assisting in audits.
- Serves as technical expert for cleaning validation.
- Suggest and sometimes may implement innovation and continuous improvement within cleaning validation.
- Influences and persuades so as to bring about technical and process improvements.
- Attend identified training, required to fulfill the role of Validation Engineer.
- Assist in the development of training material for cleaning validation activities.
- Participate in cross-functional teams as required.
- Deputise for the Validation Team Leader when designated.
- Domestic and international travel may be required.
- Proven Cleaning Validation experience of a min of 3 years is essential Degree Qualified
DESIRABLE:
- The person will have a proven track record in the qualification of any of the following systems: o Qualification of Cell Culture Technologies. o Qualification of Purification - Chromatography and Ultrafiltration Technologies. o Qualification of Production Support Equipment. o Qualification of Clean Utilities. o Qualification of HVAC (ISO classes 5 to 8). o Qualification of Control Systems - Emerson DeltaV, Honeywell Building Management Systems and Siemans PLCs.
- Qualification experience in a project environment within the pharmaceutical or biopharmaceutical industries.
- Knowledge and Interpretation of FDA/EMEA requirements applicable to the pharmaceutical or biopharmaceutical industries. Ability to apply CGMP regulations and guidelines to all aspects of qualification activities.
If you are interested in hearing more about this position then please contact me on or reply with your most recent CV. Likewise if you know of anyone who would be suitable feel free to get in touch as we offer successful referral vouchers.