Materials, Science and Technology Engineer (MS&T) in Lenoir, NC at Apex Life Sciences

Date Posted: 5/10/2018

Job Snapshot

Job Description


Currently seeking an experienced Engineer to join a growing team!

Please contact Lauren Pritts at 412-246-4743  or lpritts@apexlifesciences.com

DESCRIPTION OF DUTIES:

The mission of the Manufacturing, Science, and Technology team is to continuously improve the compliance, efficiency, and strategic position of the Lenoir site in harmony with global initiatives by applying technical, quality, and scientific principles to innovatively meet patient needs.  The core functions of MS&T include root cause analysis, production trending, material specification support, product characterization, product/process development, and technology transfers.

Job Task(s)

  • In collaboration with Manufacturing, Quality and other functions, lead projects to implement new pharmaceutical processes and optimize existing manufacturing processes by applying engineering principles, quality principles, and industry best practices
  • Generate and manage change requests and project plans and coordinate project activities
  • Develop, execute, and interpret engineering study outcomes to effectively propose and implement appropriate manufacturing scale strategies and solutions
  • Investigate critical manufacturing deviations using Root Cause Analysis (RCA) and risk assessment tools.  Develop and implement corrective actions to manufacturing excursions to ensure a reliable supply of product and prevent reoccurrence
  • Assemble and analyze manufacturing data (i.e. process parameters, critical quality attributes, defect rates) to evaluate process robustness
  • Commitment to collaboration and cross functional teamwork with other business units and global sites
  • Knowledge and application of statistics, Design of Experiments (DoE), Quality by Design (QbD), Process Analytical Technologies (PAT) and lean Six Sigma tools

Physical Demand(s)

  • While performing the duties of this job, the employee is occasionally required to don Personal Protective Equipment (PPE) and cleanroom garments.

Computer Skill(s)

  • To perform this job successfully, an individual should have knowledge of MS Office Suite, project management software (i.e. MS Project), and statistical software (i.e. Minitab, JMP)

EDUCATION AND SKILLS REQUIRED:

  • Bachelor’s Degree in Engineering, Chemistry, Biology or other life/physical science

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