19401897-Cleaning Validation Technical Specialist -Dublin Contractor

This is a 12-month contract.

Purpose:

The Cleaning Validation Technical Specialist will support the cleaning validation activities for the cGMP manufacture of biological bulk drug substance (BDS)  facility in Dublin. The Cleaning Validation Technical Specialist will be responsible for validation and verification of the cleaning used to support the technology transfer of new or existing drug substance manufacturing processes to the facility and will be required to work in close collaboration with Process Development, Engineering, Supply Chain, Quality, Regulatory, and other involved departments. The position is accountable for the timely completion of cleaning validation/verification-related milestones, with particular emphasis on cleaning validation for a multi-product drug substance manufacturing facility.

Responsibilities:

• Maintain/update input to the Cleaning/Validation Master Plan to support the multi-product drug substance

• Develop and implement/update cleaning strategies for fixed and mobile parts.

• Development/update 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.

• Author and review process transfer/cleaning documentation, cleaning risk assessments, technical protocols and reports, cleaning verification/validation documents, and supporting documentation as required.

• 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 to occur.

• Work closely with colleagues within the Technical Services team, and with Quality, Commissioning, Manufacturing Operations, and Automation MCS to ensure CIP recipes, batch record instruction, and standard work practices meet the needs of technology transfer, and routine manufacturing timelines in the context of cleaning verification/validation.

• Prioritize cleaning verification/validation activities in line with the project schedule to ensure the product submission timeline is met, and regulatory approval attained.

• Support cleaning monitoring activities. Which involves authoring documentation, coordination, and execution of cleaning monitoring runs.

• 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.

• Provide on-the-floor support for troubleshooting cleaning-related issues and may 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.

• Lead the execution of cleaning trials and studies on the manufacturing floor at a commercial scale relating to typical BDS manufacturing areas. Temporary shift working may be required during periods of engineering batch and validation batch execution, and participation in on-call roster.

Requirements:

• Minimum requirement B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.

• 1 – 3 Years of Experience