Senior Process Engineer – Aseptic Fill Finish

Intellectt Inc; Bloomington (IN); On-site; USD 85,000 - 110,000; Full time

Job summary

Intellectt Inc is seeking a Senior Process Engineer to drive process optimization and operational improvements within a pharmaceutical manufacturing environment. The ideal candidate should have hands-on experience with aseptic filling operations and automated vial filling equipment, along with strong troubleshooting and process optimization skills.

This position involves collaboration with manufacturing, engineering, and quality teams, emphasizing compliance with cGMP and regulatory requirements while supporting continuous improvement initiatives.

Qualifications

• Experience in pharmaceutical, biotech, or CDMO manufacturing environments.
• Experience with EMA and/or Optima filling lines preferred.
• Reliability engineering experience is a plus.

Responsibilities

• Optimize fill line, isolator, and manufacturing process performance.
• Troubleshoot aseptic processing and implement process improvements.
• Collaborate with manufacturing, engineering, and quality teams to improve efficiency.

Skills

Hands-on experience with aseptic filling operations

Troubleshooting and process optimization skills

Knowledge of cGMP regulations

Education

Bachelor’s degree in Engineering or related technical field

Tools

Automated vial filling equipment

Isolators

Job description

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.