Quality Assurance Engineer
3 days ago
About the Role
We are seeking a highly skilled Cleaning Engineer to join our team in a global biopharmaceutical leader with over 50 years of expertise in large-scale biotech manufacturing. As a key member of our project team, you will participate in investigating design, constructability, schedule and cost for new purification facilities.
The successful candidate will have a strong background in Good Manufacturing Practice (GMP) and Active Pharmaceutical Ingredients (API) manufacturing, with experience in unit operations, pharmaceutical processes and documentation.
You will be responsible for performing tests, ensuring all documentation is in place, and validating Cleaning-in-Place (CIP) of all process equipment. Additionally, you will take on professional responsibility for pharmaceutical processes and equipment.
Main Responsibilities
- Participate in project activities such as design review, design risk assessments, FAT and SAT.
- Perform tests and ensure all documentation is in place.
- Perform validation of CIP of all process equipment, including ownership of CIP specific processes.
- Take on professional responsibility for pharmaceutical processes and equipment.
Requirements
- Bachelor's degree in natural science, engineering or similar field.
- Strong experience within GMP and ideally API manufacturing.
- Solid understanding of unit operations, pharmaceutical processes and documentation.
- Knowledge and experience related to design review and validation of CIP, considered an advantage.
- Full professional proficiency in written and verbal English.
About Us
As a global biopharmaceutical leader, we produce half of the world's insulin and a number of biopharmaceutical products. Our team of dedicated employees work together to make a difference every day for millions of people living with diabetes and other chronic diseases.
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