Engineer I

Summary:

The Process Engineer will provide technical support for vaccine, biologic, and sterile manufacturing processes in a cGMP environment. This role involves data analysis, troubleshooting, change control implementation, and process optimization. The ideal candidate will have strong problem-solving skills, a hands-on approach, and the ability to work in cross-functional teams to improve manufacturing efficiency and compliance.

Key Responsibilities:

• Provide technical support for vaccine, biologic, and sterile manufacturing processes
• Analyze data, troubleshoot issues, and implement corrective and preventative actions
• Support change control implementation and process improvements
• Conduct technical investigations and recommend solutions for process deviations
• Write, review, and enhance SOPs for equipment and processes
• Participate in process and equipment safety reviews
• Perform shift work as needed to support manufacturing operations

Education & Experience Requirements:

B.S. or M.S. degree in Biology, Biochemistry, Biochemical Engineering, Biological Systems Engineering, Biomedical Engineering, Chemical Engineering, Computer Science, Integrated Science, or related disciplines
0-3 years of relevant industrial experience
Beta-lactam exposure required – candidates must have no known allergy

Required Skills:

• Excellent academic record
• Strong verbal and written communication skills
• Ability to work collaboratively in a team environment
• Hands-on problem-solving skills with a proactive approach
• Ability to examine issues from multiple perspectives (safety, compliance, automation, process, equipment, people)
• Initiative-taking mindset and enthusiasm for continuous learning
• Preferred Experience & Skills
• cGMP industry experience (work, co-op, or internship)
• Experience with technical investigations, troubleshooting, and report writing
• Knowledge of vaccine, biologic, or sterile manufacturing processes
• Experience conducting safety and compliance reviews
• Familiarity with change control procedures and process improvements