Pharma Process Engineer - Lean, Validation & CAPA

RXinsider LTD.; El Paso (TX); Hybrid; USD 85,000 - 120,000; Full time

Benefits offered by this job

null

Job summary

Becton, Dickinson, and Company (BD) seeks a skilled engineer to support pharmaceutical manufacturing operations in a fast-paced, regulated environment. You will analyze processes, drive improvements, and contribute to CAPAs and investigations, ensuring quality and compliance.

Responsibilities include process validation, qualification, and cross-functional collaboration across Quality, Regulatory Affairs, and Operations. A BS in engineering and experience in regulated manufacturing are required.

Qualifications

• Experience in FDA-regulated, cGMP, validation, and quality systems.
• Experience in pharmaceutical manufacturing and aseptic or sterilization processes preferred.
• Knowledge of process validation, IQ/OQ/PQ, and risk management preferred.
• Lean Six Sigma Green Belt or Black Belt preferred.

Responsibilities

• Provide day-to-day engineering support to pharmaceutical manufacturing operations.
• Analyze manufacturing processes to improve efficiency, quality, yield and cost.
• Lead root cause investigations related to deviations and customer complaints.
• Support process validation, equipment qualification, and revalidation activities.
• Coordinate engineering projects from conception through implementation.

Skills

Analytical thinking

Problem solving

Data analysis

Cross-functional collaboration

Communication

Education

Bachelor's degree in Chemical Engineering, Industrial Engineering, Mechanical Engineering, Biomedical

Tools

SAP

TrackWise

MES

Job description

Becton, Dickinson, and Company (BD) seeks a skilled engineer to support pharmaceutical manufacturing operations in a fast-paced, regulated environment. You will analyze processes, drive improvements, and contribute to CAPAs and investigations, ensuring quality and compliance.

Responsibilities include process validation, qualification, and cross-functional collaboration across Quality, Regulatory Affairs, and Operations. A BS in engineering and experience in regulated manufacturing are required.