Support Coordinator for CSV/CSA Activities

vor 4 Wochen

Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Medical Care Vollzeit

Objective of the Role:

The CSV/CSA Support and Validation Coordinator is tasked with upholding the integrity, quality, and compliance of the GPDM Polarion Tool through comprehensive Computer System Validation (CSV) and Computer Software Assurance (CSA) initiatives. This position involves collaboration with the CSV/CSA lead, coordinating efforts across various teams globally, and ensuring that all validation and assurance processes adhere to regulatory and internal standards.

Key Responsibilities:

  • Facilitate CSV/CSA initiatives for the GPDM Polarion Tool.
  • Assist the CSV/CSA lead within the Global PDM Team.
  • Plan and synchronize all CSV/CSA activities among FMC CSV/CSA teams (EMEA and NA) to enable coordinated system releases.
  • Support the creation of technical documentation and CSV/CSA deliverables based on input from various work streams and FMC global topic owners.
  • Oversee CSV activities for ALM systems and manage the interfaces between ALM, PLM, and ERP systems.
  • Contribute to the development and revision of the PCP to ensure compliance with CSA protocols.
  • Assist in addressing CSA discrepancies and provide training to project members on CSA-related topics.
  • Ensure all CSA documentation adheres to good documentation practices (GDP) and is organized in the correct sequential order.
  • Conduct quality gate reviews and validate business-critical activities prior to business go-live.
  • Create and manage the go-live approval sheet (GLAS).
  • Maintain CSA documentation for regulatory assessments and supervise all CSA activities.
  • Provide technical writing support for CSA documentation.

Qualifications:

  • Bachelor's degree in Engineering, Computer Science, Information Technology, or a related discipline. An advanced degree (Master's, PhD) in a relevant field is preferred.
  • Further education or certification in Computer System Validation (CSV), Computer Software Assurance (CSA), or related fields is highly desirable.
  • A minimum of 5 years of experience in CSV/CSA activities and IT system validation, preferably within a regulated industry such as medical devices, pharmaceuticals, or biotechnology.
  • Extensive experience in program/project management and quality assurance in a regulated environment, with a strong grasp of FDA Quality System Regulations (QSR), 21 CFR Part 11, and GAMP5 guidelines.
  • Demonstrated ability to manage multiple validation projects and coordinate with cross-functional teams.
  • Strong analytical and problem-solving capabilities, with the ability to manage complex validation tasks.
  • Excellent communication and interpersonal skills, capable of effective collaboration with global teams and stakeholders.
  • High attention to detail and a commitment to quality and compliance.
  • Ability to work independently and take initiative in a fast-paced, dynamic environment.
  • In-depth understanding of ALM (Application Lifecycle Management), PLM (Product Lifecycle Management), and ERP (Enterprise Resource Planning) systems.
  • Familiarity with tools such as Polarion, Windchill, Thingworx, and Azure DevOps.
  • Proficient in English; proficiency in German is an advantage.
  • Advanced skills in digital technologies and IT systems relevant to CSV/CSA activities.
  • Knowledge of industry best practices and regulatory requirements for system validation in a global context, particularly regarding Windchill and Polarion.
  • Willingness to travel globally up to 20% of the time.
  • Flexibility to work hours, including weekends or shifts, as needed to meet project deadlines.

Career Development: We offer an opportunity to contribute to life-saving treatments and enhance healthcare outcomes. Our commitment to your ongoing development is paramount, and you will be part of a dedicated team that inspires one another.

Diversity and Inclusion: Joining Fresenius Medical Care means being part of a team that values diversity and strives to create an inclusive atmosphere where all employees feel valued.

Stability: Our focus on innovation and continuous improvement has established us as a market leader in hemodialysis machine production, providing employees with the stability and security necessary to enhance patient lives.

Learning Opportunities: We provide access to world-class business school programs, leadership development, and ongoing training for healthcare professionals and manufacturing staff.

Work-Life Balance: We promote a better work-life balance through flexible working hours, part-time models, and remote work options.

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