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
Required Skills:
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
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 p...
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
Required Skills:
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
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