Validation Engineer

Technical Operations

Thörishaus, Bern, Switzerland

Summary Description
PaxVax is looking to recruit an experienced professional into the role of Validation Engineer.

The role is responsible for developing a core competency in process and cleaning validation and processes from the GMP scale production during late phase clinical runs through PPQ campaigns, and commercial campaigns, as well as identifying and leading technical investigations and providing technical advisement to Manufacturing Technical Support engineers.

This position is responsible for being the primary statistical process control data analyst and technical problem solver for processes entering the commercial production phase of their process lifecycle. This role may have other process validation responsibilities as assigned, but will primarily be in charge of validation planning, validation execution support, retrieve process data, analyse the data, look for positive and adverse trends, correlate the findings, solve technical issues as noted by the data analysis for process improvement/ refinement, and create written reports about the exercise.

Main tasks:

  • Perform all functions associated with process validation support,
  • Author and perform the technical review of deviations and planned deviations, change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), perform activities for lot release (assess deviations and process changes).
  • Make recommendations for process changes and sponsor these to the larger process team.
  • Author and lead process risk analysis, critical process parameter and critical quality attributes identification
  • Provide data, analyses, write-ups, reviews, and other input to annual product reviews (APR) and author continued process verification report
  • Actively drive improvements for PV, OPS, and MTS practices and procedures.
  • Identify potential root causes of variation and deviations using a systematic approach. Expertise in use / application of variety of problem solving tools e.g. Ishikawa, Kepner-Tregoe (KT), five-whys, etc. Resolve complex problems and lead multidisciplinary teams in developing and implementing solutions.
  • Represent Process Validation on project teams and interfaces with customer technical and Quality representatives once a project has reached commercialization. Represent Process Validation on internal teams (e.g. Deviation and project management meetings).
  • Participate in Customer and Regulatory Audits. Regularly interact with site and global leadership on matters concerning several functional areas and/or customers.
  • Work on CAPA and Deviations with minimal but some oversight to achieve quality, timely results.

Main Requirements

  • Bachelor’s degree in Chemical or Biological Engineering
  • Self sufficient, initiative
  • Excellent written (especially technical writing) and verbal communication skills in German and English
  • Experience with large scale process validation and/or manufacturing support (mammalian process preferred
  • Biotech industry experience in commercial scale manufacturing operations. Disposable technology experience preferred