Senior R&D Clinical Manufacturing Engineer

Lake County, IL, US
Sep 08, 2019
Required Education
Bachelors Degree
Position Type
Full time
  • Operations: Leads engineering activities, including the troubleshooting of manufacturing equipment, facilities and utilities related issues; Conducts training with dept. staff to ensure equipment is operated with minimal errors; Executes capital projects on time and within approved budgets. Leads validation discussions and execution plans with QA on quality related topics associated with equipment/facility/utility installations and changes.
  • Supervision: May supervise pilot plant engineering technicians and junior exempt staff including daily scheduling of activities, managing personnel development, holding technicians accountable against performance expectations, and writing and delivering performance reviews.
  • Product Development: Collaborates with formulators and process engineering on process development or packaging design supporting research activities occurring in the pilot plant. Provides key pilot plant equipment capability insight on these activities.
  • Technical Support: Possess detailed knowledge of pilot plant equipment and processing capabilities. Provide technical guidance to manufacturing personnel. Provides leadership with troubleshooting and identifies solutions to issues that arise during manufacturing; Provides strategic technology and productivity improvement activities; actively participates in functional area improvement initiatives.
  • Compliance: May represent department during internal and external Quality audits in regards to Engineering and Validation compliance. Understands and follows cGMP requirements, established policies; Writes and follows procedures and practices; Conducts validation activities needing minimal deviations or exceptions; Follows established safety requirements, reports incidents/near misses and recommends improvements.
  • Project Coordination: Plans and Executes all phases of capital projects including Front End Planning, RCE writing, cost control and validation. Works with purchasing to negotiate favorable terms for new capital equipment. May perform these functions within the pilot plant or other areas such as clinical packaging, NCE and NBE laboratories.
  • Communication: Prepares written and oral communication effectively through formal and informal channels. Accurately records, tabulates and reports engineering study and validation results using the necessary tools (Reports, memos, spreadsheets, etc.); Reports significant issues to management with appropriate sense of urgency; Collaborate and share information with other plants and commercial plants that may benefit.
  • Leadership: Direct activities of equipment manufacturers, custom fabricators, construction contractors, and technicians in a matrix environment. Provides project management support to other departments as needed. Makes recommendation to plant management of new technology or improvements to existing systems and processes.

  • B.S. in Engineering or related scientific area or equivalent and relative work experience.
  • 7+ years of experience in operations, and/or related area
  • Experience in a cGMP environment is highly desire d