In this role you will be responsible for supporting assigned projects as a CSV Engineer, ensuring that all processes adhere to established standards and guidelines. Your expertise will be crucial in executing CSV tests, creating necessary documentation, and collaborating with various teams to ensure compliance throughout the project lifecycle.

Project Duration: 12 Months

Starting Date: ASAP

Key Responsibilities

  • Act as the subject matter expert (SME) for CQV/CSV standards
  • Serve as the primary CSV contact for the assigned system until handover to operations
  • Participate in system impact assessments as the CSV SME
  • Collaborate with the EMR and Package Units vendor to determine optimal design for vertical integration
  • Create and manage CSV documentation in accordance with established SOPs and guidelines
  • Organize and facilitate reviews of CSV documents, ensuring final QA approval
  • Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT)
  • Develop test protocols and execute testing procedures
  • Work closely with the CSV Lead or CQV Lead to ensure project alignment
  • Ensure compliance of SGIE projects with global CQV guidelines and local procedures, identifying and resolving gaps
  • Represent CSV during inspections as the project representative

Candidate Profile

  • Technical degree (Bachelor level) in engineering or applied science; postgraduate qualification preferred
  • Significant experience in automation and vertical integration, particularly in regulated environments
  • Minimum of 5+ years in commissioning, qualification, and validation, with a focus on complex pharmaceutical projects. Familiarity with biologics and chemical manufacturing is a plus
  • Proven experience in planning CQV activities and managing key performance indicators (KPIs) in the pharmaceutical industry
  • Strong knowledge of ISPE GAMP5 and ASTM guidelines, with a track record of managing complex projects in EMA/FDA regulated environments
  • Experience in people management, including coaching and development
  • Excellent collaboration and influencing skills, with a strong ability to work in a matrix environment
  • Strong analytical skills, capable of conducting in-depth analysis of complex data sets to support decision-making
  • Ability to work independently and in team-oriented settings
  • Skilled in prioritizing tasks and executing them in a fast-paced environment
  • Strong written and oral communication skills
  • Willingness to train and support colleagues
  • Languages: Proficient in English & German

Job ID 41180378