Bioengineer V (Auto-injector)

Goldbelt Professional Services specializes in providing expert resources for Public Health missions including scientific, technical, and administrative support from junior staff to high-level subject matter experts. Research and data driven, Goldbelt Professional Services' experts create solutions customized to the client's needs.

Summary:

The Autoinjector (Bioengineer V) for the JPM CBRN Task Order 3 contract in the CTO Program Office shall serve as a subject matter expert to provide services necessary to evaluate manufacturing processes and review deliverables to assist in the development of auto-injector products, including associated Food and Drug Administration (FDA) regulated activities. Provide medical device expertise in reviewing design control documentation, regulatory device documentation, evaluating design team performance and evaluating engineering systems input and output for device manufacture and development.

Essential Job Functions:

• The contractor shall provide input to project planning and execution and provide input to risk mitigation precautions.
• The contractor shall analyze and provide input to possible risk to cost schedule and performance in the development effort.
• The contractor shall analyze plans and provide risk mitigation input to potential risk to cost, schedule and performance for the GMP manufacturing processes development, scale-up, technical transfer, and validation stages of the project.
• The contractor shall provide input to the team to establish a compliant Quality Management System (QMS) with an operational quality unit (Quality Assurance & Quality Control units) to support cGMP manufacturing operations, including device development.
• The contractor shall provide input to project schedule, cost estimation and budget management.
• The contractor shall provide input to autoinjector Integrated Product Team (IPT) meetings as follows:
  • Monitor and report on the standards employed by autoinjector 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.
  • 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 DoD acquisition documents that include FDA regulatory requirements or impact the drug development timeline.
  • Review and provide written feedback on technical records generated during the development process for accuracy and adequacy.
  • Evaluate change control documentation to determine product impact.

Necessary Skills and Knowledge:

• The contractor shall be an expert with in-depth knowledge of combination products, specifically auto-injector manufacturing, and development, to include the following:
  • Device development
  • Design for Six Sigma
  • Device reliability
  • Engineering design and drawings
  • Manufacturing process development
  • Component development - molding processes
  • Cartridge fill/finish and primary container closure systems
• Shall be an expert with 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.
• Shall be an expert with 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.).
• Shall be an expert with familiarity with 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 < tel:880.5860 > and 21 CFR 880.6920 < tel:880.6920 >; etc.).
• Proficiency with Microsoft Office, to include Outlook, Project, PowerPoint, Excel, and Word.

Minimum Qualifications:

• PhD in Molecular Biology, Biochemistry, Microbiology, or Biochemical Engineering with extensive knowledge of Virology or Vaccinology, or a related discipline, as well as fifteen (15) years of general experience and ten (10) years of relevant experience.
  • Tradeoff Requirement: The contractor shall possess a Master's degree in Molecular Biology, Biochemistry, Microbiology, or Biochemical Engineering with extensive knowledge of Virology or Vaccinology, or a related discipline, as well as twenty (20) years of general experience and fifteen (15) years of relevant experience.
• Shall be an expert with 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).
• Have experience with relevant risk assessment and problem-solving techniques (e.g., Failure Mode Effects Analysis (FMEA), fault trees, root cause analyses, etc.).

Pay and Benefits

The salary range for this position is $130,000 to $175,000 annually.

At Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.