Description
Cleaning validation engineer required to join a global pharmaceutical company located in the South West UK for an initial 6 month contract.Role and responsibilities:
- Generate and execute cleaning validation protocols as required. Provide input to Standard Operating Procedures (SOPs) and Work Instructions (WI) to enable suitable cleaning sampling activities.
- Author and review process transfer documentation, cleaning risk assessments, technical protocols and reports, cleaning validation documents and supporting documentation as required.
- Prioritise cleaning verification/validation activities in line with the project schedule to ensure product submission timeline is met, and regulatory approval attained.
- Identify and implement improvements where feasible.
- Provide on the floor support for troubleshooting cleaning related issues and to lead manufacturing investigations into process deviations.
- Author and review technical documents for SOPs, master data, material specifications and/or regulatory agency submissions which related to cleaning activities.
- Serve as a subject-matter expert on cleaning validation activities during regulatory agency inspections.
- Minimum 5 years' experience in a cleaning validation capacity.
- Technical and operational knowledge of Cleaning validation/verification, quality systems and regulatory requirements across multiple health authorities.
- Experience of cleaning validation is a must, and/or cleaning approaches to multiproduct is advantageous.
- Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.
- Good interpersonal skills coupled with demonstrated ability to effectively work in a Matrix organisation.
- Minimum requirement B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.
If this is you please apply today.