Bern, Berne, Switzerland
CQV professional working in a greenfield environment covering facilities, utilities, clean rooms and CTUs. previous roles include: lead Validation Engineer for validation activities for (new) biopharmaceutical processes in the Late-Stage Development department. primarily responsible for sterilisation validation activities on autoclaves/isolators and aseptic processes Ceaning validation (cleaning execution, verification, sampling, PW load/cycle development, CHT/DHT/SHT having been site SME for internal and external audits (F.D.A/swiss medic etc) Highly proficient in continuing validation/requalification of cold chain units such as CTUs, freezers, warehouses and walk in units. Strong quality assurance professional with a Bachelor's degree focused in Microbiology from University College Cork and a MSc in pharmaceutical validation technology from TU Dublin.
(Fill& Finish/APS/sterilisation activities) • Define strategy, plan, coordinate and complete all phases for supporting validation activities such as cleaning validation, sterilization, clean rooms performance qualification, hold time validation or mixing validation • Define strategy, plan and coordinate of aseptic process simulation (APS) • Support execution of Lifecycle Process validation activities such as process performance qualification (PPQ) • Authoring, review and approve validation plans, protocols, reports • Bridging with multi-functional teams handling and ensuring equipment and process readiness for production • Operational handling of Change Controls, CAPAs and Non-Conformances related to process validation and supporting validation activities • Establish validation standards authoring of standard operating procedures, work instructions and technical presentations in support of a flexible and agile clinical supply chain • Perform risk/criticality assessments, technical and GMP related documentation • Interacting with Engineering, Quality, Process Development, Quality Control and Production departments in a campus-wide validation team • Lead a team of external validation partners • Act as Subject Matter Expert (SME) during internal and external audits/inspections
Cleaning Validation: • Maintain/update input to the Cleaning/Validation Master Plan to support the multi-product drug substance manufacturing facility. • 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. • 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. • Author and review process transfer/cleaning documentation, cleaning risk assessments, technical protocols and reports, cleaning verification/validation documents, and supporting documentation as required. • Prioritize cleaning verification/validation activities in line with the project schedule to ensure the product submission timeline is met, and regulatory approval is attained. • Identify requirements for process, plant, or laboratory studies/trials to support cleaning verification/validation activities and 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 related to cleaning activities. • Serve as a subject-matter expert on cleaning validation activities during regulatory agency inspections.
validation specialist currently working in the Cleaning validation/clean utilities work stream consisting of the following duties: Cleaning validiation: -Cycle development -Trouble-shooting issues with and optimizing cleaning cycles and/or cleaning equipment -Generating cleaning validation protocols and summary reports -Executing cleaning validation protocols, including visual inspection and sampling and coordination with other support groups (e.g. operations, maintenance, lab, etc.) -Author and/or revise cleaning procedures and associated work instructions Utilities: -WFI qualification -clean steam qualification -HVAC qualification
• Work with core functions (Manufacturing, engineering, supply chain, QC) to close revalidation protocols • update protocols as necessary • Ensure all equipment installed is safe, effective and in compliance with industry standards • Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements. • Reviews, edits and approves deviation notifications, deviation investigations and corrective actions. • Reviews, edits and approve change controls, SOPs, reports and other documentation • Trains/advises less experienced specialists. • Manages projects and prepares status reports. • Oversee contingent workers. • Liaise with operations to request windows for revalidation • Generate and execute documentation for cGMP validation, requalification, and periodic review of systems, equipment and manufacturing processes, including validation plans, annual revalidation plan, risk assessments, IQ/OQ/PQ protocols and reports to maintain the equipment in a validated state. • Provide routine equipment technical support and troubleshooting for resolution of issues • Manage CTU/Warehouse requalification program. • Manage vendor activities, review and approval of associated vendor documentation