Computer System Validation (CSV) Lead Lab Execution Systems (LES) Position Available In Wake, North Carolina
Tallo's Job Summary: The Computer System Validation Lead - Lab Execution Systems (LES) is responsible for executing the CSV strategy and deliverables for global and Lab Execution Supporting Systems. This role requires a Bachelor's degree in Engineering or Computer Sciences, 7+ years of experience in CSV methodologies, and knowledge of industry standards. CSL Behring is hiring for this position, which can be based in Melbourne, Australia or overseas.
Job Description
Your RoleThe Computer System Validation Lead – Lab Execution Systems (LES), will be responsible for executing the Computerized System Validation (CSV) strategy and deliverables for global and Lab Execution Supporting Systems and related interfaces. This role is part of a global function and can be based from our manufacturing sites in Melbourne, Australia or overseas.
Your ResponsibilitiesReporting to the Global CSV Lead you will:
Implement LES CSV strategy across CSLManage the CSV program for Lab Execution Systems and application interfacesOwner of the LES validation strategy in alignment with QualityOversee the preparation, delivery, and execution of CSV deliverables for Lab Execution SystemsCoordinate with Quality, Site and Global validation team to build alignment of LES validation expectations and maintain the validated state of LES platformsDevelop processes and maintain platformsManage System Development Lifecycle and validated state of LES platformsAccountable for the Periodic Review process for documentation and systemsUse validation lifecycle management applications such as Kneat to support CSV phasesYour ExperienceBachelor’s in Engineering, Computer Sciences, or similar field7+ years’ experience with CSV methodologies in Lab Execution Systems, operation IT, OT, or Automation position with a good understanding of pharma, biologics and chemistryExperience in writing, reviewing and executing CSV documents in a
GAMP 5 CSV
frameworkDemonstrated knowledge and experience with CSV, SDLC, and Data Integrity principlesExperience with Lab Execution Systems technologies that may include Laboratory Information Management Systems (LIMS), Chromatography Data Acquisition System (CDAS) and Laboratory Data Management systemsKnowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Part 820, Annex 11, GAMP5Experience using ALM platforms such as Kneat and Codebeamer to support CSVOur BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces inclusion and belonging. Learn more about Inclusion & Belonging at CSL.Do work that matters at CSL Behring!
PDN-9ee5f788-7618-4eba-8de2-416262babec3
