Process Engineer (Contract - Onsite - Athens, Georgia)

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

This will be a 6-month contract (40 hrs/week) for our client in Athens, GA. Hours 8-5pm by default but can be flexible depending on business needs, equipment availability, etc.

Responsibilities

The Process Engineer has the responsibility of providing manufacturing support of current processes and process improvement initiatives as well as providing support to Capital Project initiatives to install new process equipment, production facilities, and/or process utilities. The position is the SME (Subject Matter Expert) for aseptic manufacturing processes.

• Analyze new and existing processes.

• Eliminate sources of contamination, waste, and risk.

• Optimize efficiency and yield. Identify and drive corrective actions.

• Lead without authority.

• Manage projects related to risk reduction and/or process improvement.

Skills(Required)

• Engineer

• Process Engineer

• Process Improvement

• Project Management

• Optimization

Skills (Preferred)

• Extensive direct experience in a leading role with the design, implementation, formal qualification, optimization and troubleshooting of aseptic manufacturing processes and equipment.

• Relevant processes include but are not limited to: Bioreactors, Fermenters, Concentration/filtration, Chromatography, Cell propagation, CIP/SIP (Clean-In-Place and Sterilize-In-Place).

Education/Certifications

• Eight-plus (8+) years applicable experience engineering or scientific in nature in a GMP environment.

• Experience with GAMP Automation practices and documents.

• Basic working knowledge of Allen-Bradley and/or Siemens PLCs (Programmable Logic Controllers).

• Lean Six Sigma Green Belt (or higher) certification.

• Certified Maintenance & Reliability Professional (CMRP) certification.

• Five-plus (5+) years' experience leading projects.

• Experience using, developing, and leading recognized process optimization tools in a manufacturing facility.