CSV and CSA Validation Specialist

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, orchestrating efforts across diverse FMC teams worldwide, and ensuring that all validation and assurance protocols align with regulatory and internal benchmarks.

Key Responsibilities:

  • Facilitate CSV/CSA initiatives for the GPDM Polarion Tool.
  • Assist the CSV/CSA lead within the Global PDM Team.
  • Organize and manage all CSV/CSA activities among FMC CSV/CSA teams (EMEA and NA) to ensure synchronized system releases across FME.
  • Support the technical documentation and creation of CSV/CSA deliverables based on input from various work streams and FMC global topic leaders.
  • Coordinate CSV efforts for ALM systems and oversee the interfaces between ALM, PLM, and ERP systems.
  • Engage in the development and revision of the PCP to guarantee adherence to CSA protocols.
  • Assist in resolving CSA discrepancies and provide training to project members on CSA-related subjects.
  • Ensure all CSA documentation complies with good documentation practices (GDP) and is systematically organized.
  • Conduct quality gate reviews and validate business-critical activities prior to business go-live.
  • Develop and manage the go-live approval sheet (GLAS).
  • Maintain CSA documentation for regulatory assessments and supervise all CSA operations.
  • Provide technical writing assistance for CSA documentation.

Qualifications:

  • Bachelor's degree in Engineering, Computer Science, Information Technology, or a related discipline; an advanced degree (Master's, PhD) is preferred.
  • Further education or certification in Computer System Validation (CSV), Computer Software Assurance (CSA), or related fields is highly advantageous.
  • A minimum of 5 years of experience in CSV/CSA activities and IT system validation, ideally within a regulated sector such as medical devices, pharmaceuticals, or biotechnology.
  • Extensive background in program/project management and quality assurance in a regulated setting, with a solid grasp of FDA Quality System Regulations (QSR), 21 CFR Part 11, and GAMP5 guidelines.
  • Demonstrated ability to manage multiple validation projects and collaborate with cross-functional teams.
  • Strong analytical and problem-solving capabilities, adept at managing intricate validation tasks.
  • Exceptional communication and interpersonal skills, effective in collaborating with global teams and stakeholders.
  • High attention to detail and a commitment to quality and compliance.
  • Ability to work autonomously and take initiative in a fast-paced, dynamic environment.
  • Comprehensive 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 a plus.
  • Advanced skills in digital technologies and IT systems pertinent 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 varied hours, including weekends or shifts, as necessary to meet project deadlines.

Career Opportunities:

Joining Fresenius Medical Care provides an opportunity to contribute to life-saving treatments and enhance healthcare outcomes. We are committed to supporting your professional development and fostering a collaborative team environment that inspires excellence.

Diversity and Inclusion:

At Fresenius Medical Care, we celebrate diversity and strive to create an inclusive workplace where every employee feels valued.

Stability and Growth:

Our innovative products and continuous improvement in renal therapies position us as a market leader, offering employees stability and security in their roles.

Learning and Development:

We provide access to world-class training programs and resources to support your ongoing professional growth.

Work-Life Balance:

We promote a healthy work-life balance through flexible working arrangements and opportunities for personal fulfillment.

  • CSV/CSA Compliance Coordinator

    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 responsible for maintaining the integrity, quality, and compliance of the GPDM Polarion Tool through comprehensive Computer System Validation (CSV) and Computer Software Assurance (CSA) processes. This position involves collaboration with the CSV/CSA lead, coordinating activities across...

  • 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...

  • Validation and Assurance Coordinator

    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 entails collaboration with the CSV/CSA lead, orchestrating efforts across...

  • Validation Support Coordinator

    vor 4 Wochen

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

    Objective of the Role:The CSV/CSA Validation Coordinator is tasked with maintaining the integrity, quality, and compliance of the GPDM Polarion Tool through comprehensive Computer System Validation (CSV) and Computer Software Assurance (CSA) initiatives. This position supports the CSV/CSA lead, coordinating efforts across various teams globally, ensuring...

  • Validation Specialist in Pharma

    vor 4 Wochen

    Bad Homburg vor der Höhe, Hessen, Deutschland customfield3 Vollzeit

    Position Overview:We are seeking a dedicated professional to join our organization as a Validation Specialist. In this capacity, you will be tasked with the preparation of essential documentation for the qualification of pharmaceutical manufacturing equipment and will conduct qualifications at client locations. Your role will be pivotal in ensuring adherence...

  • Validation Specialist for Pharma Processes

    vor 4 Wochen

    Bad Homburg vor der Höhe, Hessen, Deutschland customfield3 Vollzeit

    Position Overview:We are seeking a skilled professional to join our organization as a Validation Specialist. In this capacity, you will be tasked with the preparation of essential documentation for the qualification of pharmaceutical manufacturing equipment and will conduct qualifications at client locations. Your role will be pivotal in ensuring adherence...

  • Validation Specialist for Pharma Processes

    vor 4 Wochen

    Bad Homburg vor der Höhe, Hessen, Deutschland customfield3 Vollzeit

    Position Overview:We are seeking a skilled professional to become part of our team as a GMP Validation Consultant. In this position, you will be tasked with the preparation of essential documentation for the qualification of pharmaceutical manufacturing equipment and executing qualifications at client locations. Your role will be pivotal in ensuring...

  • Validation Specialist in GMP

    vor 4 Wochen

    Bad Homburg vor der Höhe, Hessen, Deutschland Pharmaplan GmbH Vollzeit

    Become a vital part of our organization as a GMP Qualification Consultant.At Pharmaplan GmbH, we are a premier engineering partner in Europe, dedicated to the design and execution of comprehensive pharmaceutical manufacturing facilities for our industrial clientele. We focus on sustainable solutions and prioritize the professional growth of our employees...

  • Quality Assurance Specialist and QMS Manager

    vor 4 Wochen

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

    Objective of the Role: The Quality Assurance Specialist and QMS Manager plays a pivotal role in assisting senior Quality Specialists to ensure the successful execution and upkeep of the Quality Management System (QMS) within the IT division. This position emphasizes operational support across a range of quality assurance functions to maintain standards...

  • GMP Qualification Consultant

    vor 4 Wochen

    Bad Homburg vor der Höhe, Hessen, Deutschland customfield3 Vollzeit

    Position Overview:We are seeking a skilled professional to become part of our team as a Validation Specialist. In this position, you will take charge of preparing essential documentation for the qualification of pharmaceutical process equipment and will conduct qualifications at client locations. Your role will be pivotal in ensuring adherence to current GMP...

  • Pharmaceutical Process Qualification Expert

    vor 4 Wochen

    Bad Homburg vor der Höhe, Hessen, Deutschland customfield3 Vollzeit

    Position Overview:We are seeking a dedicated professional to join our organization as a Validation Specialist. In this capacity, you will play a crucial role in preparing essential documentation for the qualification of pharmaceutical manufacturing equipment and executing qualifications at client locations. Your efforts will ensure adherence to current GMP...

  • Consultant for Pharmaceutical Validation

    vor 4 Wochen

    Bad Homburg vor der Höhe, Hessen, Deutschland Pharmaplan GmbH Vollzeit

    Become a part of our dynamic team as a GMP Qualification Consultant.At Pharmaplan GmbH, we are a premier engineering partner in Europe, dedicated to the design and execution of comprehensive pharmaceutical manufacturing facilities for industrial clients. Our focus is on delivering sustainable solutions while promoting individual growth through customized...

  • Medical Specialist for Psychosomatics and Psychotherapy

    Vor 3 Tagen

    Bad Homburg vor der Höhe, Hessen, Deutschland I. K. Hofmann GmbH Vollzeit

    Job Opportunity for a Medical SpecialistWe are seeking a highly skilled Medical Specialist to join our team at I. K. Hofmann GmbH. As a leading provider of medical services, we are committed to delivering exceptional care to our patients.Key Responsibilities:Provide medical expertise in psychosomatic medicine and psychotherapyDiagnose and treat patients with...

  • Medical Specialist for Psychosomatics and Psychotherapy

    Vor 3 Tagen

    Bad Homburg vor der Höhe, Hessen, Deutschland I. K. Hofmann GmbH Vollzeit

    Job Opportunity for a Medical SpecialistWe are seeking a highly skilled Medical Specialist to join our team at I. K. Hofmann GmbH. As a leading provider of medical services, we are committed to delivering exceptional care to our patients.Key Responsibilities:Provide medical expertise in psychosomatic medicine and psychotherapyDiagnose and treat patients with...

  • HR Specialist in Time Management and Payroll

    vor 4 Wochen

    Bad Homburg vor der Höhe, Hessen, Deutschland Hanon Systems EFP Deutschland GmbH Vollzeit

    Are you seeking a rewarding opportunity in the dynamic global automotive sector? Join Hanon Systems and become an integral part of our team that assists automakers in their transition towards electrification and enhancing the efficiency of traditional vehicles. Our commitment lies in fostering a sustainable future for upcoming generations through our...

  • HR Specialist in Time Management and Payroll

    vor 4 Wochen

    Bad Homburg vor der Höhe, Hessen, Deutschland Hanon Systems EFP Deutschland GmbH Vollzeit

    Are you interested in a rewarding career within the dynamic global automotive sector? Join Hanon Systems and become an integral part of our team that assists automotive manufacturers in their transition towards electrification and enhancing the efficiency of traditional vehicles. Our commitment lies in fostering a sustainable future for generations to come...

  • HR Specialist in Time Management and Payroll

    vor 4 Wochen

    Bad Homburg vor der Höhe, Hessen, Deutschland Hanon Systems EFP Deutschland GmbH Vollzeit

    Are you seeking a rewarding career in the dynamic global automotive sector? Join Hanon Systems and become an integral part of our team that aids automakers in their transition towards electrification and enhancing the efficiency of traditional vehicles. Our commitment lies in fostering a sustainable future for generations to come through our pioneering...

  • Specialist in General and Visceral Surgery

    vor 4 Wochen

    Bad Homburg vor der Höhe, Hessen, Deutschland Doc PersonalBeratung GmbH Vollzeit

    About Doc PersonalBeratung GmbH:At Doc PersonalBeratung GmbH, we pride ourselves on providing a competitive remuneration package, a robust company pension scheme, adaptable working hours, and secure employment contracts. We are in search of a qualified specialist in General and Visceral Surgery, tasked with the prevention, identification, conservative and...

  • Specialist in General and Visceral Surgery

    vor 2 Wochen

    Bad Homburg vor der Höhe, Hessen, Deutschland Doc PersonalBeratung GmbH Vollzeit

    Doc PersonalBeratung GmbH is seeking a highly motivated and skilled Specialist in General and Visceral Surgery to join our esteemed medical team.As a leading provider of comprehensive healthcare services, we offer an attractive compensation package, company pension plan, flexible work schedules, permanent employment contracts, and ongoing professional...

  • IT Audit and Compliance Specialist

    vor 4 Wochen

    Bad Homburg vor der Höhe, Hessen, Deutschland Fiserv Vollzeit

    Join a Leading Fintech OrganizationAre you an enthusiastic IT expert eager to contribute to a prominent player in the financial technology sector? Fiserv is on the lookout for a (Junior) Internal IT Governance Specialist who will play a crucial role in fostering innovation and enhancing our operational framework. Your primary focus will be on Business...