Katalysthealthcareslifesciences

Sr. Principal Engineer

Round Lake, IL, United States · Principal

Sponsorship not specifiedDetected 363 days ago
ComplianceProject ManagementClinical TrialsClinical ResearchPharmacovigilanceResearchProblem SolvingCritical Thinking

About the role

  • Job Description: - This position is a contract Packaging Engineering position within Client's Pharmaceutical segment R&D group.
  • The position may require travel to the manufacturing plants and packaging suppliers.
  • All your information will be kept confidential according to EEO guidelines.

Responsibilities

  • Lead and/or contribute to the planning and execution of packaging projects for a variety of project types including Quality/CAPA, Regulatory Compliance, Supplier Notices of Change, Cost Savings, and New Product Introductions at various domestic and international manufacturing facilities.
  • Develop protocols for testing and engage in Change Control activities interfacing with multiple functional groups, including manufacturing plants and suppliers in a team environment to execute packaging changes.
  • Plans, schedules, and collaborates with cross-functional team supporting packaging projects to achieved project objectives and milestones.
  • Expected to utilize their experience to generate cost savings ideas by recommending new materials or design modifications and resolve packaging issues by using critical thinking skills and DMAIC techniques to solve complex problems.
  • Perform financial planning and assists in the analysis to justify project approval.

Requirements

  • B.S. in Packaging or relevant Engineering degree (e.g. Mechanical, Chemical, Biomedical) with a minimum of 5 years of experience.
  • Must have experience or advanced training and demonstrate proficiency in packaging materials and processes, problem analysis and resolution, statistical methods, and design of experiments.
  • Proficient in applicable change control and development methodology and processes required to execute packaging projects.
  • Successful track record of managing packaging projects possessing a sense of urgency and commitment to meet project milestones to ensure manufacturing plants and R&D teams achieve targeted goals.
  • The ability to deal with ambiguity and effective use of creative problem solving skills.
  • Ability to organize and present technical and project management overviews with minimal assistance.
  • Manage projects with moderate complexity and scope and be required to effectively manage multiple projects with minimal assistance and supervision.
  • Create packaging material specifications, associated drawings, and packaging procedural specifications to provide the required technical information necessary to support the product/packaging configuration.
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