Senior CSV Specialist

hace 2 días

Valladolid, Valladolid, España Bacthera Spain, Sl A tiempo completo
Job Title: Senior CSV Expert

At Bacthera Spain, Sl, we are seeking a highly skilled Senior CSV Expert to join our team. As a Senior CSV Expert, you will play a critical role in ensuring that our Computer System Validations are performed according to global and local company policies and standards, as well as legal requirements and requirements set by health authorities.

Key Responsibilities:
  • Plan, develop, and execute Computer System Validations for 4 Facilities
  • Develop CSV Policies / SOP`s and Risk Assessments aligned with applicable regulatory expectations and industry standards
  • Develop protocols for CSV in accordance with policy and procedures
  • Lead assigned CSV for the process equipment of 4 facilities and provide guidance to local teams
  • Lead and support CSV projects and related activities for IT supported systems
  • Deliver a complete validation package, including URS, Validation Plan, Installation/Operational/Performance Qualification Protocol and Execution, Traceability Matrix, Validation Summary Report, and Configurations Specification
  • Coordinate the cooperation between other system stakeholders, including IT, Suppliers, and align Service Level needs
  • Coordinate/Handle CSV tasks and follow up changes and incidents for GMP/CSV relevant systems in collaboration with system Admin and IT
  • Perform yearly system review for each system and review and analyze related Deviations, CAPAs, and Changes
  • Coordinate and communicate with stakeholders to ensure accurate and timely completion
Requirements:
  • Bachelor or Master's degree in Engineering, IT, Pharmaceutical Technology, Biotechnology, or related field
  • A minimum of 5 years of experience in CSV, MES, SCADA, and OT systems
  • Good understanding of manufacturing processes and related process equipment
  • Extensive experience in a regulated pharmaceutical environment and GMP requirements
  • Ability to prioritize and manage work to critical project timelines in a fast-paced environment
  • Structured, focused, and well-organized working attitude
  • Independent way of working and taking ownership of assigned tasks
  • Working knowledge of quality systems and regulatory requirements across multiple health authorities
  • Proficient in Spanish and English
  • Ability to travel occasionally to different sites (Denmark and Switzerland)
What We Offer:
  • Start-up and innovative company within a fast decision environment
  • Flexible working hours (on site)
  • International and highly motivated team
  • Atractive salary
  • Languages courses offered

  • Senior CSV Specialist

    hace 4 semanas

    Valladolid, Valladolid, España Bacthera Spain, SL A tiempo completo

    {"h1": "Senior CSV Specialist", "h2": "Job Summary", "p": "We are seeking a highly skilled Senior CSV Specialist to join our team at Bacthera Spain, SL. As a Senior CSV Specialist, you will be responsible for ensuring that Computer System Validations are performed according to global and local company policies and standards as well as legal requirements and...

  • Senior CSV Specialist

    hace 4 semanas

    Valladolid, Valladolid, España Bacthera Spain, SL A tiempo completo

    {"h1": "Senior CSV Specialist", "h2": "Job Summary", "p": "We are seeking a highly skilled Senior CSV Specialist to join our team at Bacthera Spain, SL. As a Senior CSV Specialist, you will be responsible for ensuring that Computer System Validations are performed according to global and local company policies and standards as well as legal requirements and...

  • Senior CSV Specialist

    hace 2 días

    Valladolid, Valladolid, España Bacthera Spain A tiempo completo

    Job Title: Senior CSV ExpertAs a Senior CSV Expert at Bacthera Spain, you will play a crucial role in ensuring the quality and compliance of our Computer System Validations. Your expertise will be instrumental in planning, developing, and executing CSVs for our facilities, while also developing policies, SOPs, and risk assessments aligned with regulatory...

  • Senior CSV Specialist

    hace 2 días

    Valladolid, Valladolid, España Bacthera Spain A tiempo completo

    Job Title: Senior CSV ExpertAs a Senior CSV Expert at Bacthera Spain, you will play a crucial role in ensuring the quality and compliance of our Computer System Validations. Your expertise will be instrumental in planning, developing, and executing CSVs for our facilities, while also developing policies, SOPs, and risk assessments aligned with regulatory...

  • Senior CSV Specialist

    hace 2 días

    Valladolid, Valladolid, España Bacthera Spain A tiempo completo

    Job Title: Senior CSV ExpertAs a Senior CSV Expert at Bacthera Spain, you will play a crucial role in ensuring the Computer System Validations are performed according to global and local company policies and standards, as well as legal requirements and requirements set by health authorities.Key Responsibilities:Develop and execute Computer System Validations...

  • Senior CSV Specialist

    hace 2 días

    Valladolid, Valladolid, España Bacthera Spain A tiempo completo

    Job Title: Senior CSV ExpertAs a Senior CSV Expert at Bacthera Spain, you will play a crucial role in ensuring the Computer System Validations are performed according to global and local company policies and standards, as well as legal requirements and requirements set by health authorities.Key Responsibilities:Develop and execute Computer System Validations...

  • Senior CSV Expert

    hace 4 semanas

    Valladolid, Valladolid, España Bacthera A tiempo completo

    {"h1": "Senior CSV Expert at Bacthera", "p": "As a Senior CSV Expert at Bacthera, you will play a crucial role in ensuring the quality and compliance of our computer systems. Your primary responsibility will be to plan, develop, and execute Computer System Validations for our facilities, ensuring that they meet global and local company policies, standards,...

  • Senior CSV Expert

    hace 2 días

    Valladolid, Valladolid, España Bacthera A tiempo completo

    Senior CSV ExpertBacthera is a leading contract development and manufacturing partner (CDMO) for biotech and pharma customers. We enable our customers to bring life-changing treatments to patients. Our global presence includes headquarters in Basel (CH) and production facilities in Spain, Denmark, and Switzerland. We bring together best-in-class,...

  • Senior CSV Expert

    hace 2 días

    Valladolid, Valladolid, España Bacthera A tiempo completo

    Senior CSV ExpertBacthera is a leading contract development and manufacturing partner (CDMO) for biotech and pharma customers. We enable our customers to bring life-changing treatments to patients. Our global presence includes headquarters in Basel (CH) and production facilities in Spain, Denmark, and Switzerland. We bring together best-in-class,...

  • Senior CSV Expert

    hace 2 días

    Valladolid, Valladolid, España Bacthera Spain, Sl A tiempo completo

    Job DescriptionAs a successful CSV Engineer at Bacthera Spain, SL, you will ensure that Computer System Validations are performed according to global and local company policies and standards as well as legal requirements and requirements set by health authorities.Key ResponsibilitiesDeveloping CSV Policies / SOP`s and Risk Assessments aligned with applicable...

  • Senior CSV Expert

    hace 2 días

    Valladolid, Valladolid, España Bacthera Spain, Sl A tiempo completo

    Job DescriptionAs a successful CSV Engineer at Bacthera Spain, SL, you will ensure that Computer System Validations are performed according to global and local company policies and standards as well as legal requirements and requirements set by health authorities.Key ResponsibilitiesDeveloping CSV Policies / SOP`s and Risk Assessments aligned with applicable...

  • Senior Propulsion Systems Specialist

    hace 1 mes

    Valladolid, Valladolid, España Josh Bolus - ARCA Resourcing Ltd A tiempo completo

    About the RoleWe are seeking a highly skilled Senior Propulsion Systems Specialist to join our team at Josh Bolus - ARCA Resourcing Ltd. As a key member of our Propulsion and Attitude Control Systems team, you will play a pivotal role in designing and developing cutting-edge propulsion systems and attitude control systems (ADCS) for satellite missions.Key...

  • Automotive Industrialization Specialist

    hace 1 mes

    Valladolid, Valladolid, España PTC Group A tiempo completo

    About the RoleWe are seeking a highly skilled Automotive Industrialization Specialist to join our team at PTC Group. As a key member of our organization, you will be responsible for ensuring the convergence of Product, Process, and Technical Definition of the vehicle series.Key ResponsibilitiesConvergence Assurance: Ensure the convergence of Product,...

  • Automotive Industrialization Specialist

    hace 1 mes

    Valladolid, Valladolid, España PTC Group A tiempo completo

    About the RoleWe are seeking a highly skilled Automotive Industrialization Specialist to join our team at PTC Group. As a key member of our organization, you will be responsible for ensuring the convergence of Product, Process, and Technical Definition of the vehicle series.Key ResponsibilitiesConvergence Assurance: Ensure the convergence of Product,...

  • Senior Developer Productivity Specialist

    hace 4 semanas

    Valladolid, Valladolid, España Microsoft A tiempo completo

    About the RoleWe are seeking a highly skilled Senior Developer Productivity Specialist to join our Global Black Belt organization. As a key member of our team, you will play a pivotal role in establishing our presence in high-growth markets and driving the adoption of our Developer Tools portfolio across GitHub and Microsoft.ResponsibilitiesDevelop a...

  • Senior Developer Productivity Specialist

    hace 4 semanas

    Valladolid, Valladolid, España Microsoft A tiempo completo

    About the RoleWe are seeking a highly skilled Senior Developer Productivity Specialist to join our Global Black Belt organization. As a key member of our team, you will play a pivotal role in establishing our presence in high-growth markets and driving the adoption of our Developer Tools portfolio across GitHub and Microsoft.ResponsibilitiesDevelop a...

  • Senior Developer Productivity Specialist

    hace 4 semanas

    Valladolid, Valladolid, España Microsoft A tiempo completo

    About the RoleWe are seeking a highly skilled Senior Developer Productivity Specialist to join our Global Black Belt organization. As a key member of our team, you will play a pivotal role in establishing our presence in high-growth markets and driving the adoption of our Developer Tools portfolio across GitHub and Microsoft.ResponsibilitiesDevelop a...

  • Senior IT Support Specialist

    hace 4 semanas

    Valladolid, Valladolid, España NovoScale Is Now Thirdera A tiempo completo

    Senior IT Support AnalystWe are seeking a highly skilled Senior IT Support Analyst to join our team at Novo/Scale Is Now Thirdera. As a key member of our IT operations, you will be responsible for maintaining the stability and functionality of our technology environment, delivering exceptional user experiences, and collaborating with cross-functional teams...

  • Senior IT Support Specialist

    hace 4 semanas

    Valladolid, Valladolid, España NovoScale Is Now Thirdera A tiempo completo

    Senior IT Support AnalystWe are seeking a highly skilled Senior IT Support Analyst to join our team at Novo/Scale Is Now Thirdera. As a key member of our IT operations, you will be responsible for maintaining the stability and functionality of our technology environment, delivering exceptional user experiences, and collaborating with cross-functional teams...

  • Freelance Recruitment Specialist

    hace 1 mes

    Valladolid, Valladolid, España David Kennedy Recruitment A tiempo completo

    Job SummaryDavid Kennedy Recruitment Ltd is seeking a highly skilled and experienced Freelance Recruitment Specialist to join our team. As a Freelance Recruitment Specialist, you will be responsible for sourcing, hunting, and attracting top-notch candidates for our clients' needs.Key ResponsibilitiesDive into your own sourcing channels, job boards, social...