Pharma Process Engineer: Lean, GMP & Process Optimization

RXinsider LTD.; El Paso (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

BD seeks a skilled engineer to support pharmaceutical manufacturing operations in a highly regulated environment. You will analyze processes, drive efficiency, quality, yield, and cost improvements, and lead CAPAs and investigations.

Responsibilities include validation, qualification, audits, and continuous improvement projects. Collaboration with multiple functions and adherence to FDA/cGMP standards are essential.

Qualifications

• Bachelor’s degree in Chemical Engineering, Industrial Engineering, Mechanical Engineering, Biomedical or related field.
• 3+ years of engineering experience in pharma, medical device, biotech, or highly regulated manufacturing.
• Experience in FDA-regulated, cGMP, validation and quality systems.
• Experience in pharmaceutical manufacturing and aseptic or sterilization processes preferred.
• Knowledge of process validation, equipment qualification (IQ/OQ/PQ), and risk management.
• Lean Six Sigma Green Belt or Black Belt certification preferred.
• Experience with SAP, TrackWise, MES or similar manufacturing systems preferred.

Responsibilities

• Provide day-to-day engineering support to pharmaceutical manufacturing operations.
• Analyze manufacturing processes to identify opportunities to improve efficiency, quality, yield and cost.
• Lead CAPAs and root-cause investigations for process deviations and customer complaints.
• Support process validation, equipment qualification, and revalidation activities.
• Lead Lean Manufacturing and Continuous Improvement projects to reduce waste and improve process capability.
• Coordinate engineering projects from conception through implementation and manage timelines and risk.

Skills

Analytical skills

MS Office

Statistics

Education

Bachelor’s degree in Chemical Engineering/Industrial/Mechanical/Biomedical

Tools

SAP

TrackWise

MES

Job description

BD seeks a skilled engineer to support pharmaceutical manufacturing operations in a highly regulated environment. You will analyze processes, drive efficiency, quality, yield, and cost improvements, and lead CAPAs and investigations.

Responsibilities include validation, qualification, audits, and continuous improvement projects. Collaboration with multiple functions and adherence to FDA/cGMP standards are essential.