Process Advisor

1 month ago
Company
Noblis ESI
Requisition #
5770
Security Clearance
Secret
FT/PT/On-Call
Full Time
Job Category
Biology and Chemistry

Responsibilities

In this role, Process Advisor will:

  • Participate in product development teams.  
  • Ensure all areas specific to device manufacture are in the right development order and appropriate for the development effort.  
  • Review on-going technical efforts to assess appropriateness and identify gaps in the current device design and manufacturing development pathway. In addition, the contractor shall report on appropriateness and gaps in device design and manufacturing.  
  • Support FDA submission of auto-injectors. As part of this task, the Advisor shall:  
    • Evaluate the adequacy of human factors and functional testing to determine the appropriateness of studies (i.e., methodology, conduct, and reporting)  
    • Ensure that studies will meet FDA requirements  
    • Report on the results found
  • Monitor and report on the standards employed by auto-injector manufacturers and how the standards are employed in the development or production of auto-injectors.  
  • Prepare reports to evaluate the use and completion of risk assessment and problem-solving techniques by companies developing auto-injectors.  
  • Review and report on Design History Files supporting combination products, including auto-injectors, to assure they are current, robust, and meet all FDA, ASTM, American National Standards Institute (ANSI), and ISO requirements.  
  • Provide input and assist in the development of regulatory strategies, target product profiles, and other regulatory documents related to the design, manufacture, and assembly of the device, obtaining input from subject matter experts as needed.  
  • Review regulatory strategies related to technical manufacturing for accuracy and consistency.  
  • Evaluate Department of Defense (DoD) acquisition documents that include FDA regulatory requirements or impact the drug development timeline. 
  • Review and provide written feedback technical records generated during the development process for accuracy and adequacy.  
  • Evaluate change control documentation to determine product impact.  
  • Evaluate contract proposals specific to the manufacturing development plan.  
  • Ensure that protocols, data collection forms, and subsequent study reports are consistent and accurate, and that data support stated results.  
  • Conduct on-site visits to ensure that data collected is supported by the raw data. The contractor shall prepare a report after each visit, to be shared with the entire development team, to convey observations made and how site procedures comply with applicable standards and/or regulations.  
  • Evaluate the testing facility, ensuring that its personnel and equipment meet minimum requirements identified within FDA combination product regulations and guidance documents.  
  • Maintain interpersonal contacts to increase effective team dynamics; effectively communicating ideas, requirements, and scientific knowledge across and within organizations united for the development of medical countermeasures.

Qualifications

  • Standard Requirement: The contractor shall possess a PhD in Engineering, Science, Systems Management, Business Management, or a related discipline, as well as ten (10) years of general experience and six (6) years of relevant experience in the medical device and combination product industry.
  • Alternate/Tradeoff Requirement: The contractor shall possess a Master’s degree in Engineering, Science, Systems Management, Business Management, or a related discipline, as well as twelve (12) years of general experience and eight (8) years of relevant experience in the medical device and combination product industry. 
  • The contractor shall possess demonstrated experience providing advice, developing documents, and reviewing deliverables to Integrated Product Teams (IPTs) and/or working groups for development of auto-injector products. 
  • The contractor shall possess in-depth knowledge of combination products, specifically auto-injector manufacturing and development, to include the following: 
    • Device development 
    • Engineering design and drawings 
    • Component development molding processes 
    • Cartridge fill/finish and primary container closure systems 
  • The contractor shall possess working knowledge of Design History Files, inclusive of legacy products being updated to current Good Manufacturing Practice (GMP) standards, as demonstrated in both previous experience and training courses. 
  • The contractor shall possess familiarity and experience evaluating manufacturing processes using all International Standards Organization (ISO) and American Society for Testing and Materials (ASTM) standards related to combination products (e.g., ISO standards 7886-1, 10993-1, 11608 (all parts), 10993-1, 13485, and 14971; ASTM D4169; etc.).  
  • The contractor shall possess familiarity with Food and Drug Administration (FDA) guidance for industry (e.g., “Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products”; Class II devices under 21 Code of Federal Regulations (CFR) 880.5860 and 21 CFR 880.6920; etc.). 
  • The contractor shall possess experience evaluating feedback and preparing submissions for the FDA review centers involved in the approval of combination products, particularly the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH). 
  • The contractor shall possess experience with relevant risk assessment and problem-solving techniques (e.g., Failure Mode Effects Analysis (FMEA), fault trees, root cause analyses, etc.).  
  • The contractor shall be capable of succinctly and clearly articulating plans, proposals, and concerns, both verbally during meetings and in writing via white papers or other documentation, for all products in development. 
  • The contractor shall possess skills required to be effective in a team environment (e.g., collaborative and persuasive, active listening, etc.). 
  • The contractor shall be capable of self-starting.

Overview

Noblis and our wholly owned subsidiaries, Noblis ESI and Noblis NSP, are solving difficult problems that help our government and our country. We bring the best of scientific thought, management, and engineering expertise with a reputation for independence and objectivity. We support a wide range of government and industry clients in the areas of national security, intelligence, transportation, healthcare, environmental sustainability, and enterprise engineering. Learn more at noblis.org/about.

 

Why work at a Noblis company?

Our employees find greater meaning in their work and balance the other things in life that matter to them. Our people are our greatest asset. They are exceptionally skilled, knowledgeable, team-oriented, and mission-driven individuals who want to do work that matters and benefits the public.

 

Noblis has won numerous workplace awards. Noblis maintains a drug-free workplace and is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race.

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