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Job Title: Process Engineer, Active Ingredient

Location: Athens, GA 30601

Hours/Schedule: 8 am-5 pm

Type: Contract

Responsibilities

This role 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.

Tasks & responsibilities:

• 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.

  Requirements

  Preferred requirements:

• 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/Experience:

• 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.

  Benefits

  System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.