Senior Process Engineer – Aseptic Fill Finish

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.