Technical Source is seeking a Process Engineers to join our team and support pharmaceutical manufacturing operations. This role involves optimizing production processes, ensuring compliance with GMP and regulatory standards, and contributing to continuous improvement initiatives. The ideal candidate will have strong analytical skills, a deep understanding of manufacturing processes, and experience working in a regulated environment. Specifically the ideal candidate will have experience supporting fill-finish environments
Key Responsibilities:
- Analyze, design, and improve manufacturing processes to enhance efficiency, quality, and cost-effectiveness.
- Provide technical expertise and troubleshooting support for production processes and equipment.
- Lead or assist in process-related projects, including the introduction of new equipment, scaling-up production, and implementing process changes.
- Ensure all processes and documentation comply with GMP, FDA, and other relevant regulatory requirements.
- Collect and analyze process data to identify trends, troubleshoot issues, and propose improvements.
- Work closely with cross-functional teams, including Quality, Maintenance, and Production, to ensure seamless manufacturing operations.
- Support process validation activities, including protocol development, execution, and documentation.
Qualifications
- Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or a related field.
- 4-8+ years of experience in process engineering within a pharmaceutical or biotech manufacturing environment.
- Technical Skills:
- Knowledge of GMP and FDA regulations.
- Formulation fill-finish experience
- Familiarity with process control systems and manufacturing equipment.
- Proficiency in data analysis and problem-solving methodologies.