Process Engineer II (Pharmaceutical Manufacturing)

Wilmington, OH, US • Posted 1 day ago • Updated 3 hours ago
Full Time
On-site
USD $90,000.00 - 115,000.00 per year
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Preventive Maintenance
  • Performance Management
  • Project Management
  • FOCUS
  • Continuous Improvement
  • Instrumentation
  • Procurement
  • Good Manufacturing Practice
  • Process Control
  • OSD
  • Pharmaceutics
  • Statistics
  • Analysis Of Variance
  • Regression Analysis
  • Manufacturing Operations
  • System Integration Testing
  • Manufacturing

Summary

Pay Rate Low: 90000 | Pay Rate High: 115000

Our client is a global biopharmaceutical company seeking a ProcessEngineer II to support commercial and clinical pharmaceutical manuacturing, with a focus on oral solid dosage (OSD) products.

Title: Process Engineer II (Pharmaceutical Manufacturing)
Salary: $90-115K +Bonus
Hours: 1st shift ~8am-5pm M-F
Location: Onsite in Wilmington, OH (Excellent Relocation assistance provided if needed!)
Summary

The Process Engineer supports commercial and clinical pharmaceutical manufacturing, with a focus on oral solid dosage (OSD) products. This role is responsible for process scaleup and transfer, equipment selection and commissioning, and continuous improvement of manufacturing and packaging operations.

Essential Functions
  • Troubleshoot and maintain manufacturing systems, processes, and equipment.
  • Support the development or transfer of manufacturing and cleaning processes for the manufacturing area.
  • "Hands-on" ability to install and troubleshoot instrumentation and equipment.
  • Author high-quality technical protocols/reports (engineering studies, summary reports, equipment specifications, change controls, and investigations)
  • Specify and size manufacturing systems, equipment, and process equipment.

Basic Qualifications:
  • BS degree in Engineering or technical discipline.
  • 2-5 year of manufacturing experience or technical experience.

Preferred Qualification:
  • 2-5 years of OSD pharmaceutical experience or 5 years of pharmaceutical engineering experience.
  • Experience with OSD equipment procurement.
  • Thorough knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations.
  • Thorough knowledge of OSD operations, statistics, equipment design, process control, and process scale-up.
  • Knowledge of OSD pharmaceutical process and equipment validations.
  • Experience in statistical analysis: sample sizing, ANOVA, regression analysis, control charts, etc
  • MUST be authorized to work in the US without sponsorship

Physical Demands
  • Ability to properly gown and don PAPR for potent controlled substance formulations for extended periods of time
  • Ability to lift/move 40 lbs. overhead. Ability to team lift up to 100 lbs.
  • Must be able to be medically cleared for respirator use (PAPR)
  • Ability to operate different types of production equipment.
  • Ability to gown correctly for clean room manufacturing operations.
  • Ability to stand or sit for extended periods (up to 2 hours at a time).
  • Must be able to work in an office and a manufacturing environment.

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Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 10522794
  • Position Id: cdfa52f6daa7ac35ec55f5f19717890e
  • Posted 1 day ago
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