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Process Development Engineer

Minnetonka, MN 55441

Posted: 01/23/2023 Employment Type: Contract Job Category: Project Management Job Number: 537481 Is job remote?: No Country: United States

Job Description

  • POSITION SUMMARY:
  • Pay Rate Range: $80-100/hr

    This position is the company subject matter expert on temperature-controlled (cold chain) processes used to manufacture products. This position will understand the regulatory requirements and provide expertise to establish and implement cost-effective temperature controlled (cold chain) processes, equipment, and logistics to ensure a cGMP and GDP compliant supply chain. This position will also manage the project timeline and budget, and collaborate with internal and external teams to identify project constraints and achieve project goals.  

    Products include but are not limited to combination pharmaceutical/medical devices used for self-injection.

    ESSENTIAL DUTIES AND RESPONSIBILITIES:

    Responsibilities include, but are not limited to:
  • Develop and implement cold chain processes, equipment, and logistics to minimize time of product outside of cold chain
  • Provide knowledge, experience, and training to drive cold chain industry best practices throughout the organization
  • Ensure cold chain quality assurance system is in place that meets all required global regulations
  • Develop and implement all documentation for cold chain processes and controls including but not limited to: standard operating procedures, batch records, training documentation, pFMEAs, process/equipment validations (IQ/OQ/PQ)
  • Establish control plans to ensure cold chain requirements are met throughout manufacturing process from external component supplier shipments through device assembly/packaging and finished goods shipments
  • Manage external contractors to implement and validate required facilities equipment
  • Define roles and responsibilities for all employees and suppliers involved in cold chain processes
  • Identify, recommend, and qualify cost effective and compliant solutions for packaging, transit, and off-site storage
  • Design and develop manufacturing processes and equipment that are lean and mistake-proof
  • Develop specifications and work with suppliers to quote, procure, and implement cold chain related equipment
  • Develop process validation plans, lead the execution of plans, and document results in reports
  • Collaborate with Operations team to develop effective process work instructions
  • Implement equipment calibration and maintenance plans/schedules
  • Design experiments and gather/assess/summarize data using statistical tools to make conclusions and decisions
  • Lead cross-functional teams to develop and manage project plans and schedules
  • EDUCATIONAL REQUIREMENTS (degree, license, certification):
  • Bachelor’s degree in Engineering, Supply Chain, or related technical field
  • YEARS OF EXPERIENCE:
  • 7-10 years in cold chain process development or manufacturing in the pharmaceutical or similarly regulated industry
  • OTHER SKILLS AND ABILITIES:
  • Experience in medical device, pharmaceutical, GMP, or regulated industry
  • Ability to author technical plans and reports
  • Ability to travel up to 10% as projects require
  • Self-motivated with strong collaboration, interpersonal and communication skills that support success in a remote working situation
  • Strong technical and project management capabilities
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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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