Autoclave Engineer (GMP Manufacturing)

Job Description

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

Nice to Have

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