Senior Aseptic Manufacturing Engineer - Automation & Validation

Kindeva; Brentwood (MO); On-site; USD 120,000 - 160,000; Full time

Job summary

Kindeva seeks a Senior Manufacturing Engineer to design, implement, and optimize aseptic manufacturing processes and equipment for sterile pharmaceutical products. You will lead diagnostics, qualification, and validation activities in ISO 5/Grade A cleanrooms, while driving quality and continuous improvement across the site.

Join a cross‑functional team focusing on sterility assurance, equipment reliability, and regulatory compliance (FDA/EMA).

Qualifications

• Bachelor's degree in mechanical, chemical, biomedical, electrical engineering or closely related field.
• 5+ years of hands‑on engineering experience in a cGMP‑regulated pharmaceutical, biopharmaceutical, or sterile medical device environment.

Responsibilities

• Coordinate aseptic manufacturing processes and technical projects.
• Design, modify and qualify aseptic process equipment and systems (filling lines, isolators, RABS, autoclaves).
• Create and maintain detailed technical documentation (P&IDs, specs, 3D models, drawings).
• Troubleshoot automation systems (PLCs, HMIs, SCADA) in aseptic filling and finishing.
• Lead IQ/OQ/PQ, cleaning validation, and media fill simulations for new installs or tech transfers.
• Perform RCA, implement CAPAs, and drive improvements for yield and contamination control.
• Assist regulatory inspections and risk assessments (FMEA, HAZOP).
• Collaborate with QA, Validation, Production, Maintenance, and Automation to stay in validated state.

Skills

Aseptic processing

CAPA and RCA

Process validation

Regulatory compliance

Automation troubleshooting

Education

Bachelor's degree in Mechanical Engineering or related field

Tools

SolidWorks

AutoCAD

PLC (Allen‑Bradley / Siemens)

HMI/SCADA

OSISoft PI

Job description

Kindeva seeks a Senior Manufacturing Engineer to design, implement, and optimize aseptic manufacturing processes and equipment for sterile pharmaceutical products. You will lead diagnostics, qualification, and validation activities in ISO 5/Grade A cleanrooms, while driving quality and continuous improvement across the site.

Join a cross‑functional team focusing on sterility assurance, equipment reliability, and regulatory compliance (FDA/EMA).