Aufgaben

  • Develop and implement process-specific validation strategies in accordance with Validation Master Plan (VMP) and relevant SOPs
  • Author and review validation and study protocols/reports, including hold time, resin lifetime, buffer hold, and mixing studies
  • Facilitate and/or participate in cross-functional Risk Assessments (RA) to determine validation scopes
  • Evaluate validation data for protocol adherence; manage deviations and define corrective actions
  • Collaborate with QA to align validation documentation with regulatory and internal standards
  • Issue, review, or approve project-related documents and records such as RA, TT documents, FMEA, CRs, TCRs, and DRs
  • Assess the impact of technical or process-specific changes on existing validations; define need for re-validation if required
  • Ensure batch release readiness in cooperation with QA Operations, including approval of validation-related deviations and CRs
  • Oversee Continued Process Verification (CPV) activities: preparation and approval of CPV plans, reports, and Product Quality Reviews (PQRs)
  • Support Process Development (PD) with process characterization and risk assessments
  • Act as a technical lead in cross-functional project teams, ensuring effective collaboration with MSAT, QA Validation, Cleaning Validation, and QA Qualification
  • Represent process validation in audits and inspections by regulatory authorities and customers
  • Support training programs and mentor junior colleagues as needed
  • Contribute to fostering a culture of continuous improvement within the organization

Qualifikationen

  • University degree in Life Sciences, Biotechnology, Biochemistry, Engineering, or related field
  • Solid experience (3+ years preferred) in process validation in a GMP-regulated biopharmaceutical environment
  • In-depth knowledge of biotechnology processes, ideally mammalian large-scale production (e.g., ORCA platform)
  • Familiarity with risk assessment tools (e.g., FMEA) and regulatory standards for validation
  • Strong cross-functional communication and documentation skills
  • Fluent in English; German is a plus