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Engineering Site Project Coordinator
Ref No.: 18-00492
Location: Cincinnati, Ohio
Position Type:Contract
Start Date / End Date: 04/30/2018 to 10/12/2018

Project Description:
Production/Process Engineer supports the manufacturing of Oral Solids Dosage (OSD) manufacturing and specialized products at a dedicated hormonal facility. This role will primarily support solid oral dosage manufacturing and small project delivery. The position will apply equipment and process understanding of pharmaceutical manufacturing equipment which includes operational efficiencies, process design, specifications, vendor management, qualification, safety and asset lifecycle management. Some experience of drug product manufacturing and equipment qualification is expected. Good interpersonal, organizational, and communication skills (both oral and written) and demonstrated skills leading and working with teams to deliver projects. Will develop and deliver technical reports and presentations.
  • Responsible for manufacturing equipment and process development and support including both wet and dry granulating, fluid bed granulating, direct compression, and specialty manufacturing for commercial volumes. Should understand and propose solutions to technical challenges and be the technical expert on OSD equipment.
  • Support new equipment acquisition and be responsible for Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) of process equipment and manufacturing systems. Preparation and execution of commissioning, qualification, and validation protocols for equipment, mechanical, computer control, and utility systems.
  • Provides ongoing support to manufacturing and troubleshooting expertise to resolve process deviations, quality defects, and problems limiting throughput. May use statistical methods to measure and analyze critical process parameters and key process indicators.
  • Assist in capital planning for new equipment and upgrades to existing equipment. Will prepare user requirements, basis of design, specifications, and design qualifications of individual equipment and components.
  • Expected to review and manage the reliability of process equipment including the preventive maintenance program, break downs, and corrective actions. Will recommend spare part inventories and perform failure modes and effects analysis (FMEA) for equipment and process.
  • Will recommend and manage improvement projects and prepare scope documentations and financial cost/benefit proposals. Will, as assign, manage improvement project from conception to completion.
  • Will implement safe work practices and process controls to ensure a safe operation of equipment and facility. May include job hazard analysis, failure fault trees, and risk assessments to drive a preventable injury work place and continuously safe process.

Required Skills:
  • Bachelor of Science Project Management or ABET accredited Bachelor of Science Chemical, Mechanical or Electrical Engineering.
  • Minimum Two (2) years in pharmaceutical manufacturing.
  • Compression and granulation experience a plus.
  • Manufacturing solid oral dosage technologies or parenteral aseptic fill / finish.
  • Six Sigma Greenbelt certification a plus.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Ashley: