Validation Expert - Drug Product Process Validation; temporary

The Position

At the Kaiseraugst site, around 1,800 employees with an innovative spirit and the highest quality standards ensure the continuous supply of medicines to patients worldwide. As part of Pharma Technical Operations (PT), the site is a central pillar of sterile drug product manufacturing  MSAT Sterile Team (Manufacturing Science and Technology) actively shapes the technological advancement, validation, and optimization of aseptic processes, combining scientific expertise with GMP compliance to ensure safe, efficient, and sustainable manufacturing processes for sterile drug products.

As a Validation Expert - Drug Product Process Validation, you will be responsible for the design, execution, and GMP‑compliant documentation of product-independent process validations within sterile drug product manufacturing. Working at the interface of Production, Engineering, Quality Assurance, and global network partners, you will make a decisive contribution to process safety and inspection readiness while shaping technical concepts, strategic network initiatives, and validation standards.

• Process Validation Execution:
  Design, plan, execute, and evaluate product‑independent validation studies (e.g., Visual Inspection, Autoclaving, Sterilization‑in‑Place (SIP), Sterile Hold Time (SHT), and Crimping), including sample management, shipping, and GMP‑compliant documentation
• Technical Evaluations:
  Conduct technical assessments, root cause analyses, and prepare Quality Impact Assessments to ensure continuous process safety and quality
• Project & Process Lifecycle:
  Manage or collaborate on local and cross‑site validation projects, process improvements, and clinical Phase 3 manufacturing
• Cross‑Functional
  
  Collaboration:
  
  Partner closely with Kaiseraugst Manufacturing Units (Antibiotics & Sterile Filling), Engineering, Quality Assurance, and global network stakeholders
• Global Network & Benchmarking:
  Discuss and benchmark validation concepts with Pharma Technical Development, and represent the department in huddles, steering, and planning meetings
• Audit & Compliance Support:
  Ensure validation activities align with PQS and regulatory requirements, supporting health authority inspections, internal audits, and regulatory dossier preparation
• Technical Impact & Visibility:
  Take on a high‑visibility, interdisciplinary role with access to global know‑how and digital tools, directly contributing to the safety and quality of life‑saving medicines

• Education & Professional
  
  Experience:
  
  Completed degree in pharmacy, natural sciences, engineering, or a comparable qualification, paired with several years of professional experience
• Validation & GMP Expertise:
  Proven experience in planning, executing, and evaluating validation studies in a GMP environment, alongside a solid knowledge of sterile manufacturing processes
• Communication &
  
  Collaboration:
  
  Excellent written and verbal communication skills in both German and English, with a strong ability to collaborate cross‑functionally within a global network
• Analytical & Proactive Mindset:
  High level of initiative, systematic thinking, and a solution‑oriented working style, with a readiness to adapt to and actively shape new technologies and processes
• Passion for Improvement: A strong willingness to learn, a passion for innovation, and an affinity for continuous improvement principles (Lean Thinking, LPS)

Roche is an Equal Opportunity Employer.