Xtant Medical

Validation Engineer

Title: Validation Engineer
Status: Full-Time, Exempt
Location: Belgrade, MT

Summary:

Why Xtant Medical?

JOIN A RISING organization that is focused on the design, development, and commercialization of a comprehensive portfolio of orthobiologics and spinal fixation systems. Xtant Medical’s mission is to provide cost-effective technology and services that help clinicians efficiently perform their job.

Position Summary

Xtant Medical is seeking talented and dedicated Validation Engineer that will support the company mission to market regenerative medicine products and medical devices.   The primary responsibility of the Validation Engineer will be to generate and maintain the Company’s Master Validation Plan and lead validation activities by initiating, developing, and helping to implement validation projects to ensure Xtant processes are capable of consistently meeting their intended specifications and requirements. This includes studying existing and new processes to help identify and implement necessary validations. This position will work within the Research and Development Department, and cross-functionally with several other departments as each project requires.

Principle Duties & Responsibilities

  • Generate and maintain the Company’s Master Validation Plan and lead validation activities by initiating, developing, and helping to implement validation projects to ensure Xtant processes are capable of consistently meeting their intended specifications and requirements. Develop and manage multiple validations with a focus on establishing robust process validations while achieving cost and timeline objectives.
  • Develop and maintain an understanding of the requirements of the Food and Drug Administration (FDA) Code of Federal Regulations Title 21, Parts 820 and 1271; American Association of Tissue Banks (AATB); International Organization of Standardization (ISO) 13485; European Medical Device Directives (MDD); and Canadian Medical Device Regulations as applicable and adhere to standards and regulations to help the company lead the Medical Device and Biologics industries in quality practices.
  • Adhere to Xtant Medical Standard Operating Procedures (SOPs) and safety protocols, FDA Regulations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) and Devices; operate in compliance with FDA, AATB, ISO, and Occupational Safety and Health Administration (OSHA) Standards.
  • Develop and maintain an understanding of the Xtant Medical products and general biological and chemical systems utilized within the Department. Understand how the activities performed in the Department are controlled by and interact with the Quality System and how they affect the production of medical devices and tissues.
  • Ensure all processes are in a validated state of control, including cleaning, disinfection, sterilization, and manufacturing processes. Perform prospective, retrospective, and revalidations as needed.
  • Generate FMEA documents, validation test protocols, validation reports, other required documents, and perform statistical analysis to support validation activities. Train staff on changes to documents as needed.
  • Track validation packages to completion, establish schedule for review and potential revalidation. Review completed validation packages for compliance with regulatory, compendial, and other relevant validation requirements. Transfer completed validations into production.
  • Perform investigations associated with validation activities (e.g. deviations or OOS during validation studies).
  • Design experiments and interpret experimental data generating informed analytical decisions to support validation activities.
  • Observe and analyze operational processes to identify validation needs.
  • Work with the design and development teams as assigned on new products, implementing design for manufacturability. May assist in Design Control activities.
  • Own, maintain, and report to Department Director the financial impact of prospective, in-progress, and completed projects.
  • Prepare presentations describing proposed solutions and advise Department Head of status of projects and tasks.

Position Requirements

  • Knowledge of current Good Manufacturing Practices (cGMP) and Quality System Regulation (QSR).
  • Significant microbiological knowledge required. Experience executing cleaning/disinfection validations strongly preferred.
  • Must be able to apply statistical models to data obtained from validation activities to demonstrate validation success/failure.
  • Requires the ability to apply scientific and analytical principles for proper design of qualifications and validations.
  • Applied knowledge of project management methodologies preferred.
  • Practical knowledge of risk management processes (e.g. FMEA, etc.), statistical data analysis, and change control.
  • Significant experience with Lean Manufacturing principles, structured problem solving methodologies (Lean, Six Sigma, etc.) and process control.
  • Extensive knowledge of FDA and ISO regulations and standards required; knowledge of AATB standards preferred.
  • Proven ability to write, review, and edit technical documents.
  • Advanced ability to communicate effectively both orally and in writing and the ability to present effectively to small and large groups.
  • A demonstrated ability to perform in cross-functional teams to achieve objectives within required time frames.
  • Must demonstrate a high level of ethical behavior and possess a work ethic that includes neatness, punctuality, and accuracy.

Education/Knowledge/Skills Required

  • Bachelor’s degree or higher in an Engineering or Science field is required.
  • Minimum of 3 years direct validation experience in a pharmaceutical, biologics, medical device, or FDA related manufacturing facility is required. Validation experience should encompass cleaning, sterilization, and process validations.
  • Six Sigma Green Belt required; Black Belt preferred.
  • Must have or be willing to acquire Certified Tissue Bank Specialist (CTBS) certification.

Benefits: Xtant Medical offers competitive wages, and comprehensive Medical, Vision, Dental, 401k, Life and AD&D, and Disability insurance packages

Xtant Medical is an equal opportunity employer.  We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, or any other status protected by law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions be based on job-related factors.