Autoclave Engineer (GMP Manufacturing)

PSC Biotech is seeking an experienced Engineer with
hands -on autoclave and sterilization systems experience to support GMP
manufacturing operations. The role will focus on operation, qualification,
troubleshooting, and continuous improvement of autoclave and sterilization
processes within a regulated pharmaceutical environment.

Key Responsibilities

• Provide
  engineering support for autoclave and sterilization systems used in
  GMP manufacturing
  
• Support commissioning, qualification (IQ/OQ/PQ) and validation activities
  
• Troubleshoot
  equipment issues and lead root cause investigations
  
• Support
  deviations, CAPAs, and change controls related to sterilization processes
  
• Ensure
  compliance with GMP, safety, and quality standards
  
• Collaborate
  with manufacturing, quality, and maintenance teams
  
• Support
  equipment lifecycle activities and continuous improvement initiatives
  

Requirements

Required Experience & Skills

• Degree
  in Engineering (Mechanical, Chemical, Biomedical, or similar)
  
• Proven
  experience with autoclaves / moist heat sterilization systems
  
• Strong
  background in GMP pharmaceutical or biotech manufacturing
  
• Experience
  with equipment qualification and validation
  
• Solid
  understanding of sterilization principles and regulatory expectations
  
• Ability
  to work independently in a fast -paced environment
  
• Fluent
  in English (German is a plus but not required)
  

Nice to Have

• Experience
  working in large pharma or biotech sites