CSV_CSA Support and Validation Coordinator

Goal of Function:

The primary goal of the CSV/CSA Support and Validation Coordinator is to ensure the integrity, quality, and compliance of the GPDM Polarion Tool through rigorous Computer System Validation (CSV) and Computer Software Assurance (CSA) activities. This role involves supporting the CSV/CSA lead, coordinating efforts across various FMC teams globally, and ensuring that all validation and assurance processes meet regulatory and internal standards. The Coordinator will play a crucial role in planning, executing, and documenting validation activities, as well as in facilitating seamless integration and communication between ALM, PLM, and ERP systems.

Tasks and Responsibilities:

• Support CSV/CSA activities for the GPDM Polarion Tool.
• Assist CSV/CSA lead in the Global PDM Team.
• Plan and coordinate all CSV/CSA activities between FMC CSV/CSA teams (EMEA and NA) and work streams to enable coordinated system releases across FME.
• Support technical writing and creation of CSV/CSA deliverables based on input from work streams and FMC global topic owners.
• Coordinate CSV activities for ALM systems and manage interfaces between ALM, PLM, and ERP systems.
• Participate in the development and revision of the PCP to ensure compliance with CSA procedures.
• Assist in handling CSA discrepancies and training project members on CSA relevant topics.
• Ensure all CSA documentation follows good documentation practice (GDP) and is maintained in the correct sequential order.
• Perform quality gate reviews and verify business-relevant activities before business go-live.
• Create and manage the go-live approval sheet (GLAS).
• Maintain CSA documentation for regulatory reviews and supervise all CSA activities.
• Provide technical writing support for CSA documentation.

Education & Qualifications:

• Bachelor's degree in Engineering, Computer Science, Information Technology, or a related field. An advanced degree (e.g., Master's, PhD) in a relevant field is preferred.
• Specialized further education or certification in Computer System Validation (CSV), Computer Software Assurance (CSA), or related areas is highly desirable.
• Minimum of 5 years in CSV/CSA activities and IT system validation, preferably in 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 understanding of FDA Quality System Regulations (QSR), 21 CFR Part 11, and GAMP5 guidelines.
• Proven track record of managing multiple validation projects and coordinating with cross-functional teams.
• Strong analytical and problem-solving skills with the ability to manage complex validation activities.
• Excellent communication and interpersonal skills, capable of effectively collaborating with global teams and stakeholders.
• High attention to detail and commitment to quality and compliance.
• Ability to work independently and take initiative in a fast-paced, dynamic environment.
• Deep 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. Especially Windchill and Polarion
• Willingness to travel globally up to 20% of the time.
• Ability to work flexible hours, including weekends or shifts, as needed to meet project deadlines.