Responsible for installation, maintenance, troubleshooting, and optimization of biologics manufacturing equipment in a GMP-regulated environment. Supports equipment reliability, process improvements, validation activities, and operational efficiency initiatives.
Key Responsibilities
- Provide day-to-day technical support for manufacturing equipment.
- Troubleshoot equipment and process issues to minimize downtime.
- Develop and maintain operational procedures and training materials.
- Lead technical investigations and continuous improvement initiatives.
- Support validation protocol development and execution.
- Collaborate across functions to support lean manufacturing objectives.
- Develop expertise in aseptic filling and lyophilization systems.
Required Qualifications
- Bachelor’s degree in Engineering or related discipline, or equivalent experience.
- Experience in biologics or pharmaceutical manufacturing environments.
- Familiarity with GMP requirements and regulated operations.
Preferred Qualifications
- Experience with aseptic filling and lyophilization processes.
- Strong problem-solving, communication, and collaboration skills.
Work Environment
- Fast-paced manufacturing environment focused on operational excellence, compliance, and continuous improvement.