Senior Aseptic Manufacturing Engineer: Process & Automation

Kindeva Drug Delivery; Missouri; On-site; USD 110,000 - 150,000; Full time

Job summary

Kindeva Drug Delivery is seeking a Senior Manufacturing Engineer to design, implement, and optimize aseptic manufacturing processes and equipment for sterile products. The role emphasizes sterility assurance, process improvements, automation enhancements, and regulatory compliance across ISO 5 environments.

You will collaborate with QA, Validation, Production, Maintenance, and Automation to keep processes validated and aligned with FDA/EMA expectations, while leading CAPA activities and change

Qualifications

• Bachelor's degree in engineering (mechanical/biomedical/chemical).
• 5+ years in a cGMP regulated pharma/biopharma or sterile manufacturing environment.
• Experience supporting aseptic processing, sterile fill-finish, or cleanroom operations.

Responsibilities

• Lead aseptic manufacturing processes and equipment development and qualification.
• Design, modify, optimize, and qualify aseptic equipment including filling lines, isolators, RABS, autoclaves, CIP/SIP skids.
• Develop and maintain technical docs (P&IDs, specs, 3D models) using SolidWorks/AutoCAD.
• Troubleshoot and optimize automation (PLCs, HMIs, SCADA) in aseptic filling/finishing.
• Own or lead IQ/OQ/PQ, validation, cleaning validation, and media fill simulations.

Skills

Aseptic processing

Process optimization

Root cause analysis

Education

Bachelor's degree in engineering

Tools

SolidWorks

AutoCAD

PLC (AB/Siemens)

Job description

Kindeva Drug Delivery is seeking a Senior Manufacturing Engineer to design, implement, and optimize aseptic manufacturing processes and equipment for sterile products. The role emphasizes sterility assurance, process improvements, automation enhancements, and regulatory compliance across ISO 5 environments.

You will collaborate with QA, Validation, Production, Maintenance, and Automation to keep processes validated and aligned with FDA/EMA expectations, while leading CAPA activities and change