Cleaning Validation Engineer
Company Name: Hyde Engineering & Consulting
Location of Position: Dublin
Company URL: www.hyde-ec.com
Vacancy Type: Current Vacancy
Duties: Author, and maintain the Cleaning/Validation Master Plan to support the startup of the multi-product drug substance manufacturing facility at Alexion College Park Dublin. 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, plans and reports 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 cleaning risk assessments, technical protocols and reports, cleaning validation documents, cleaning sample maps 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. Provide oversight in the execution of cleaning trials and studies on the manufacturing floor at commercial scale relating to media/buffer preparation, and process equipment. Temporary shift working may be required during periods of engineering batch and validation batch execution. Provide on the floor support for troubleshooting cleaning verification/validation related issues and to lead manufacturing investigations into process deviations. Author/review technical documents for SOPs, master data, material specifications and/or regulatory agency submissions which related to cleaning activities. May serve as a subject-matter expert on specific cleaning verification/validation activities during regulatory agency inspections.
Level: B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.
Additional Info: 2 years’ experience in Cleaning verification/validation / Technical Services / Manufacturing / Technical Development/Quality Support in a biological bulk drug substance or drug product manufacturing organization. Technical and operational knowledge of Cleaning validation/verification, quality systems and regulatory requirements across multiple health authorities (would be advantageous). Experience of cleaning verification/validation is beneficial, 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.
Method application: Forward CV to Craig.firstname.lastname@example.org
Closing Date: 30-11-2017