Senior CSV Specialist

hace 1 mes


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

As 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 for 4 Facilities
  • Plan, develop, and execute CSV policies, SOPs, and risk assessments aligned with applicable regulatory expectations and industry standards
  • Lead assigned CSV for the process equipment of 4 facilities and provide guidance to local teams
  • Coordinate the cooperation between other system stakeholders, including IT, Suppliers, and Service Level alignment
  • Perform yearly system reviews for each system and review related Deviations, CAPAs, and Changes
Requirements:
  • Bachelor or Master's degree in Engineering, IT, Pharmaceutical Technology, Biotechnology, or related field
  • 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)
Benefits:
  • Start-up and innovative company within a fast decision environment
  • Flexible working hours (on site)
  • International and highly motivated team
  • Attractive salary
  • Language courses offered


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

    Job Title: Senior CSV ExpertAt 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...


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

    Job Title: Senior CSV ExpertAt 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...


  • 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...


  • 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...


  • Valladolid, Valladolid, España Bacthera Spain A tiempo completo

    Job SummaryWe are seeking a highly skilled CSV Validation Specialist to join our team at Bacthera Spain. As a CSV Validation 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 requirements set by health authorities.Key...


  • Valladolid, Valladolid, España Bacthera Spain A tiempo completo

    Job DescriptionAs a CSV Validation Specialist, you will play a crucial role in ensuring the Computer System Validations are performed in accordance with global and local company policies, standards, and legal requirements. You will be responsible for planning, developing, and executing Computer System Validations for 4 Facilities, reporting to the global...

  • Senior CSV Expert

    hace 1 mes


    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 1 mes


    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,...


  • Valladolid, Valladolid, España Donaldson A tiempo completo

    At Donaldson, we're committed to solving the world's most complex filtration challenges. We're a technology and innovation leader, continuously evolving to meet the filtration needs of our changing world.As a Senior Human Resources Specialist, you'll play a vital role in supervising and monitoring HR processes, including communication, recruitment, labor...


  • Valladolid, Valladolid, España Https:Www.Energyjobline.ComSitemap A tiempo completo

    Key Responsibilities:As a Battery Development Engineer at AVL Iberica, you will contribute to the development of cutting-edge battery packs. Your expertise will be crucial in designing and integrating E/E architectures, with a focus on intersystem communications. You will generate DVPs for battery pack validation, conduct thorough testing, and analyze...


  • Valladolid, Valladolid, España Ebury A tiempo completo

    Ebury is a leading FinTech firm that offers a range of innovative financial products and services. We are currently seeking a Senior Financial Crime Compliance Specialist to join our team.As a member of our Financial Crime Quality Assurance Team, you will play a crucial role in ensuring that our clients are thoroughly vetted and that our financial systems...


  • Valladolid, Valladolid, España Job Just On Business A tiempo completo

    La nostra azienda, Job Just On Business Spa, cerca un/a Specialista E-Commerce per la sua filiale di Cerea. La risorsa avrà le seguenti responsabilità:Gestione e ottimizzazione del sito e-commerce aziendale per migliorare l'esperienza utente e aumentare le vendite.Sviluppo e implementazione di strategie di marketing digitale, inclusi SEO, SEM, e-mail...

  • X-Ray Imaging Specialist

    hace 4 semanas


    Valladolid, Valladolid, España 100 Lcmc Health A tiempo completo

    Job Summary:We are seeking a skilled X-Ray Imaging Specialist to join our team at 100 Lcmc Health. As a key member of our radiology department, you will be responsible for providing high-quality imaging services to our patients.Key Responsibilities:⁠ ⁠Demonstrate technical proficiency in producing high-quality exams within the appropriate length of time...


  • Valladolid, Valladolid, España Thirdera A tiempo completo

    Senior IT Support AnalystThirdera is seeking a highly skilled Senior IT Support Analyst to join our team in Spain. As a key member of our IT operations team, you will be responsible for maintaining the stability and functionality of our technology environment, delivering exceptional user experiences, and collaborating with cross-functional teams to drive...


  • Valladolid, Valladolid, España Thirdera A tiempo completo

    Senior IT Support AnalystThirdera is seeking a highly skilled Senior IT Support Analyst to join our team in Spain. As a key member of our IT operations team, you will be responsible for maintaining the stability and functionality of our technology environment, delivering exceptional user experiences, and collaborating with cross-functional teams to drive...


  • Valladolid, Valladolid, España Thirdera A tiempo completo

    Transformative IT Support RoleThirdera, a leading ServiceNow partner, is seeking a highly skilled Senior IT Support Analyst to join our Spain team. As a key member of our team, you will play a crucial role in delivering exceptional user experiences and driving continuous improvement in our IT operations.Your Mission:As a Senior IT Support Analyst, you will...


  • Valladolid, Valladolid, España Thirdera A tiempo completo

    Transformative IT Support RoleThirdera, a leading ServiceNow partner, is seeking a highly skilled Senior IT Support Analyst to join our Spain team. As a key member of our team, you will play a crucial role in delivering exceptional user experiences and driving continuous improvement in our IT operations.Your Mission:As a Senior IT Support Analyst, you will...


  • Valladolid, Valladolid, España Evergreen Systems A tiempo completo

    About the Role:Evergreen Systems is seeking a highly skilled Senior IT Support Analyst to join our team in Spain. As a Senior IT Support Analyst, you will play a crucial role in maintaining the stability and functionality of our technology environment, delivering exceptional user experiences, and collaborating with cross-functional teams to drive continuous...


  • Valladolid, Valladolid, España Fundcraft A tiempo completo

    About Fundcraft:As a pioneering force in the fund industry, Fundcraft is revolutionizing digital-native fund operations. Our mission is to empower alternative investment managers to focus on their core business by providing simple, transparent, and integrated fund operations. With a unique approach and innovative tech-led solutions, we're committed to...


  • Valladolid, Valladolid, España Storio Group A tiempo completo

    About the Role:Storio Group is seeking a highly motivated and experienced CRM Operations Senior Specialist to join our dynamic team. As one of six CRM Operations Specialists, you'll play a crucial role in shaping and executing email campaigns for one of our brands, impacting millions of customers.Your daily adventure at Storio:Own the email channel: You'll...