Senior Aseptic Manufacturing Engineer & SME

Kindeva; Bridgeton (MO); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive salary

Bonus eligibility

Comprehensive benefits

Technical training

Job summary

Kindeva in Bridgeton, MO seeks a Senior Manufacturing Engineer to own aseptic systems, lead process optimization, and ensure compliant, high-performance manufacturing of sterile products. You will drive contamination control, equipment lifecycle management, and continuous improvement across fill-finish operations.

The role partners with QA, Regulatory, and MSAT to support tech transfers, regulatory inspections, and capital projects while mentoring junior engineers and cross-functional teams.

Qualifications

• Bachelor's degree in a related engineering discipline.
• 3+ years of hands-on engineering in a cGMP pharmaceutical, biopharmaceutical, or sterile medical device environment.
• Experience with isolator technology, RABS, filling lines, lyophilization, aseptic connections, and closed-system processing.

Responsibilities

• Act as SME for aseptic manufacturing equipment, utilities, and fill-finish systems.
• Provide technical leadership for aseptic fill/finish operations including scale-up and validation.
• Ensure robust aseptic practices and contamination control strategies across sterile operations.
• Lead or support equipment and process lifecycle activities (IQ/OQ, FAT/SAT, requalification).
• Author, review, and approve SOPs, batch records, deviations, CAPAs, and validation reports.

Skills

Aseptic manufacturing

Lean Six Sigma

Equipment validation

Process optimization

Data analytics

Regulatory knowledge

Education

Bachelor's degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or related technical discipline

Tools

SolidWorks

AutoCAD

PLC programming

HMI/SCADA

OSisoft PI

Job description

Kindeva in Bridgeton, MO seeks a Senior Manufacturing Engineer to own aseptic systems, lead process optimization, and ensure compliant, high-performance manufacturing of sterile products. You will drive contamination control, equipment lifecycle management, and continuous improvement across fill-finish operations.

The role partners with QA, Regulatory, and MSAT to support tech transfers, regulatory inspections, and capital projects while mentoring junior engineers and cross-functional teams.