What are the responsibilities and job description for the Senior Process Engineer – Aseptic Fill Finish position at Intellectt Inc?
Position Summary:
Seeking a Senior Process Engineer to drive process optimization and operational improvements within a pharmaceutical manufacturing environment. The ideal candidate will have hands-on experience with aseptic filling operations, isolators, automated vial filling equipment, and process troubleshooting in a cGMP-regulated setting.
Key Responsibilities:
- Optimize fill line, isolator, and manufacturing process performance.
- Troubleshoot aseptic processing and implement process improvements.
- Support operations involving automated vial filling equipment, isolators, and associated support systems.
- Collaborate with manufacturing, engineering, and quality teams to improve efficiency and reliability.
- Support development, revision, and maintenance of SOPs, batch records, and process documentation.
- Drive continuous improvement initiatives in a fast-paced manufacturing environment.
- Support filling operations, autoclave processes, and manufacturing investigations.
- Ensure compliance with cGMP and regulatory requirements.
Required Qualifications:
- Bachelor’s degree in Engineering or related technical field.
- Experience in pharmaceutical, biotech, or CDMO manufacturing environments.
- Hands-on experience with aseptic processing and filling operations.
- Experience with automated vial filling equipment and isolators.
- Strong troubleshooting and process optimization skills.
- Knowledge of cGMP regulations and manufacturing documentation practices.
- Experience with EMA and/or Optima filling lines preferred.
- Reliability engineering experience is a plus.