- Develop and implement cleaning strategies for fixed and mobile parts.
- Development and/or optimize cleaning (CIP) cycles/methods/recipes for buffer and media preparation systems, upstream (bioreactors) and downstream equipment trains, parts washers and supporting process equipment.
- 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.
- Work closely with colleagues within the Technical Services team, and with Quality, Commissioning, Manufacturing Operation, and Automation MCS to ensure CIP recipes, batch record instruction and standard work practices meet the needs of startup, technology transfer, and routine manufacturing timelines in the context of cleaning validation.
- Author and review process transfer documentation, cleaning risk assessments, technical protocols and reports, cleaning validation documents and supporting documentation as required.
- Prioritize cleaning verification/validation activities in line with the project schedule to ensure product submission timeline is met, and regulatory approval attained.
- Identify requirements for process, plant, or laboratory studies/trials to support cleaning verification/validation activities and to liaise closely with Operations/QC to oversee the design and execution of studies (as required).
- Identify and implement improvements where feasible.
- Lead the execution of cleaning trials and studies on the manufacturing floor at commercial scale relating to media/buffer preparation. Temporary shift working may be required during periods of engineering batch and validation batch execution.
- 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 requirement B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.
- Minimum 5 years' experience in Technical Services / Manufacturing / Technical Development/Quality Support in a biological bulk drug substance manufacturing organization 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 organization.
- Ability to present and successfully defend technical and scientific approaches in both written and verbal form.
- Ability to drive for results independently and adapt to rapidly changing priorities
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