Senior Cleaning Validation Expert 100% (f/m/d)


Offered by:

Bacthera AG


As a successful CV Engineer you ensure that Cleaning Validation is performed according to global and local company policies and standards as well as legal requirements and requirements set by regulatory authorities. You are responsible for planning, developing and executing the Cleaning Validation for Drug Substance and Drug Product Processes in CAPEX- and OPEX-projects. 

Roles and Responsibilities

  • Develops cleaning validation Policies / SOP`s and Risk Assessments aligned with applicable regulatory expectations and industry standards
  • Development of protocols for cleaning validation in accordance with policy and procedures
  • Executes / oversees cleaning validation, supporting documentation, protocols and reports as well as analytical testing
  • Leads assigned cleaning validation studies across multiple sites and provides guidance to local teams. Coordinates and communicates with stakeholders to ensure accurate and timely completion of studies
  • Provides expertise in cleaning processes on a wide variety of production equipment for Active Pharmaceutical Ingredient (API) and Drug Product (DP).
  • Analyzes study results for CV protocols and performs periodical assessment of validity of cleaning process efficacy
  • Reviews and analyzes related Deviations, CAPAs and Changes

Your Profile

  • Bachelor or Master’s degree in Pharmaceutical Technology, Chemistry, Biotechnology or equivalent scientific degree
  • A minimum of 5 years of experience in Cleaning Validation
  • od understanding of manufacturing processes and related process equipment
  • Extensive experience in a regulated pharmaceutical environment and GMP requirements
  • Fundamental understanding of standard pharmaceutical analytical testing and microbiology as well as Pharmacopeias (EP, USP)
  • Ability to prioritize and manage work to critical project timelines in a fast-paced environment
  • Structured, focused and well-organized working attitude
  • Self-dependent way of working and taking ownership of assigned tasks
  • Working kledge of quality systems and regulatory requirements across multiple health authorities
  • Proficient in German and English
  • Ability to travel occasionally to different sites

 You will be based in Basel, Switzerland or Hoersholm, Denmark and will report to the Head of Qualification/Validation.Are you interested to work for an innovative, dynamic and future oriented start-up company? If you are looking for a new challenging role were you can bring in your experience and leave your footprint then send us your full application to Ms. Céline Künzi, HR Business Partner; [email protected]