Computerised System Validation Expert

4 giorni fa


Parma, Emilia-Romagna, Italia Massimi Sistemi S.R.L. A tempo pieno
Job Title: Computerised System Validation Specialist

We are seeking a highly skilled Computerised System Validation Specialist to join our team at Massimi Sistemi S.R.L. in Parma, Italy.

About the Role

The ideal candidate will have at least two to three years of operational experience in the pharmaceutical and/or biotech industry, specifically in CSV (Computerised System Validation), validation protocols, and Validation Plan, IQ/OQ/PQ processes.

Key Responsibilities
  • Independently manage the design and execution of tests.
  • Provide client support in software system validation.
  • Develop validation plans, conduct tests, collect and evaluate results, and prepare validation reports.
  • Define and write Validation Plans, Validation Reports, Test plans, Acceptance tests, User Requirements, etc.
  • Manage of Change Control and Periodic Review processes.
  • Conducting Data Integrity Assessments.
  • Writing and reviewing Standard Operating Procedures and Work Instructions.
  • Drafting of Design and Functional Specification documents in cooperation with our System or Process Engineers and managing formal revision and approval processes.
  • Writing and executing IQ/OQ/PQ test protocols for computer systems, processes, equipment and utilities.
  • Performing Technical Impact Assessments.
  • Writing and reviewing Calibration and Maintenance Plans.
  • IT/OT Infrastructure Qualification plan, tests and procedures writing and review.
Requirements
  • Very good knowledge of pharma standards and regulations (ISPE GAMP and GxP, EUDRALEX, FDA CFR 21, etc.).
  • Language skills: Italian and English CEFR C1 level or higher (read, written and spoken).
  • Utmost professionalism and seriousness towards customers and colleagues.
What We Offer
  • Internal and external training programs.
  • Performance bonuses.
  • Overtime pay in compliance with regulations.
  • Team building activities.

MAASI Enterprises want to be an inclusive and equitable company, we value differences, and welcome people from all walks of life. We believe in equal opportunities for everyone and we apply fair working conditions and salaries related to assigned responsibilities, skills and personal merit.



  • Parma, Emilia-Romagna, Italia Data Rover A tempo pieno

    Computerised System Validation SpecialistWe are seeking a highly skilled Computerised System Validation Specialist to join our team at Data Rover. As a key member of our Life Sciences sector, you will be responsible for ensuring the validation of computerised systems in the pharmaceutical and biotech industry.ResponsibilitiesIndependently manage the design...


  • Parma, Emilia-Romagna, Italia Maasi Enterprises Ltd A tempo pieno

    {"title": "Computerised System Validation Specialist", "description": "Job SummaryWe are seeking a highly skilled Computerised System Validation Specialist to join our team at Maasi Enterprises Ltd. The ideal candidate will have a strong background in CSV, validation protocols, and validation plans, with a proven track record of delivering high-quality...


  • Parma, Emilia-Romagna, Italia Data Rover A tempo pieno

    {"h3": "Computerised System Validation Specialist Role", "p": "At Data Rover, we are seeking a skilled Computerised System Validation Specialist to join our team. As a key member of our Life Sciences sector, you will be responsible for ensuring the validation of computerised systems, processes, and equipment.Responsibilities:* Design and execute tests to...


  • Parma, Emilia-Romagna, Italia Massimi Sistemi S.r.l. A tempo pieno

    {"h3": "Computerised System Validation Specialist Role Overview"} We are seeking a skilled Computerised System Validation Specialist to join our team at Massimi Sistemi S.r.l. in Parma, Italy. Key Responsibilities Develop and execute validation plans, protocols, and reports for computer systems and processes. Provide client support in software system...


  • Parma, Emilia-Romagna, Italia Data Rover A tempo pieno

    {"h3": "Computerised System Validation Specialist Role at Data RoverWe are seeking a skilled Computerised System Validation Specialist to join our team at Data Rover. As a CSV Specialist, you will be responsible for managing the design and execution of tests, providing client support in software system validation, and developing validation...


  • Parma, Emilia-Romagna, Italia Gruppo MAASI A tempo pieno

    About the RoleWe are seeking a highly skilled Computerised System Validation Specialist to join our team at Gruppo MAASI. As a CSV Specialist, you will play a crucial role in ensuring the validation of computer systems and processes in the pharmaceutical and biotech industries.Key ResponsibilitiesDevelop and execute validation plans, protocols, and reports...


  • Parma, Emilia-Romagna, Italia MAASI Enterprises Ltd A tempo pieno

    Job SummaryWe are seeking a highly skilled Computerised System Validation Specialist to join our team at MAASI Enterprises Ltd. As a CSV Specialist, you will play a critical role in ensuring the validation of computer systems and processes in the pharmaceutical and biotech industry.Key ResponsibilitiesDesign and execute tests to validate computer systems and...


  • Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

    About the RoleWe are seeking a highly skilled Global Process Validation SME to join our Corporate Products Industrialization department. As a key member of our team, you will be responsible for coordinating maintenance activities on in-market products, ensuring compliance with regulatory frameworks, and collaborating with internal and external...


  • Parma, Emilia-Romagna, Italia Ambarella A tempo pieno

    Software EngineerWe are seeking a skilled Software Engineer to contribute to the development of cutting-edge automotive ADAS and Autonomous Driving applications.The ideal candidate will have expertise in developing and integrating real-time computer vision algorithms and deep learning models in proprietary embedded systems.Key Responsibilities:Develop and...


  • Parma, Emilia-Romagna, Italia Ambarella A tempo pieno

    Software Engineer OpportunityWe are seeking a skilled Software Engineer to contribute to the development of cutting-edge automotive ADAS and Autonomous Driving applications at Ambarella.The successful candidate will play a key role in the development, porting, and integration of advanced algorithms and ML models in proprietary embedded...


  • Parma, Emilia-Romagna, Italia Sidel A tempo pieno

    About the RoleWe are seeking a highly skilled SAP Business Expert to join our Supply Chain Processes, Systems and Digitalization Team within Operational Excellence and SC Transformation function at Sidel. The primary mission of this role is to define the optimized SAP template to manage factories through a unified Manufacturing System in collaboration with...


  • Parma, Emilia-Romagna, Italia Sidel A tempo pieno

    About the RoleWe are seeking a highly skilled SAP Business Expert to join our Supply Chain Processes, Systems and Digitalization Team within Operational Excellence and SC Transformation function at Sidel. The primary mission of this role is to define the optimized SAP template to manage the factories through a unified Manufacturing System in collaboration...


  • Parma, Emilia-Romagna, Italia Sidel A tempo pieno

    About the RoleWe are seeking a highly skilled SAP Business Expert to join our Supply Chain Processes, Systems and Digitalization Team within Operational Excellence and SC Transformation function at Sidel. The primary mission of this role is to define the optimized SAP template to manage the factories through a unified Manufacturing System in collaboration...


  • Parma, Emilia-Romagna, Italia Sidel A tempo pieno

    Job SummarySidel is seeking an experienced Aseptic Field Coordinator to join our team. As a key member of our aseptic field team, you will be responsible for leading site activities related to aseptic equipment installation, start-up, validation, and commissioning.Key ResponsibilitiesLead all site activities (projects and services) related to aseptic...


  • Parma, Emilia-Romagna, Italia Sidel A tempo pieno

    About the RoleWe are seeking an experienced Aseptic Field Coordinator to join our team at Sidel. As a key member of our aseptic field team, you will be responsible for leading all site activities related to aseptic equipment installation, start-up, validation, and commissioning.Key Responsibilities:Lead site activities, including installation, start-up,...


  • Parma, Emilia-Romagna, Italia The European Food Safety Authority A tempo pieno

    About the RoleWe are seeking a highly skilled Scientific Data Steward to join our team at The European Food Safety Authority. As a key member of our organization, you will play a crucial role in ensuring the accuracy, integrity, and quality of our scientific data.Key ResponsibilitiesData Collection and Validation: Collaborate with data providers,...


  • Parma, Emilia-Romagna, Italia Chiesi Farmaceutici A tempo pieno

    About Chiesi FarmaceuticiChiesi Farmaceutici is a leading international pharmaceutical and healthcare group with over 85 years of experience. We operate in 31 countries with a team of over 7,000 employees. Our mission is to improve people's quality of life by acting responsibly towards society and the environment.Job SummaryWe are seeking a highly skilled...


  • Parma, Emilia-Romagna, Italia Chiesi A tempo pieno

    About UsChiesi is a leading international pharmaceutical and healthcare group with a rich history of innovation and excellence. With a strong presence in 31 countries and a team of over 7,000 employees, we are committed to improving people's quality of life through responsible and sustainable practices.Our MissionWe strive to be a trusted partner in the...


  • Parma, Emilia-Romagna, Italia FORTNA A tempo pieno

    About the RoleFORTNA is a leading provider of innovative solutions for omnichannel and parcel distribution operations. We partner with top brands to transform their operations and stay ahead of digital disruption. As a Senior Mechanical Project Engineer, you will play a critical role in designing and delivering solutions that optimize order fulfillment and...


  • Parma, Emilia-Romagna, Italia FORTNA A tempo pieno

    About the RoleFORTNA is a leading provider of innovative solutions for omnichannel and parcel distribution operations. We partner with top brands to transform their operations and stay ahead of digital disruption. As a Senior Mechanical Project Engineer, you will play a critical role in designing and delivering solutions that optimize order fulfillment and...