Medical Device Process Validation Engineer/Consultant

VTI Life Sciences-posted 16 days ago
Mid Level
Naples, FL
51-100 employees
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VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industry. We are looking for a Process Validation Engineer/Consultant for our Naples, Florida area medical device client to lead and coordinate validation execution activities with operations and engineering teams for special process related areas (Laser marking, Laser welding, Passivation, and injection molding processes). This role is expected to start on 12 JAN 2026 and run through 12 JUN 2026 (5 months).

  • Lead and coordinate validation execution activities with operations and engineering teams for special process related areas (Laser marking, Laser welding, Passivation, and injection molding processes).
  • Write equipment and process validation protocols (IQ, OQ, PQ) and reports for equipment used for manufacturing medical devices such as metal instruments/ implants, ABS/Peek instruments/implants.
  • Execute validation protocols for manufacturing equipment such as Laser marking, Laser welding, Passivation, and injection molding processes.
  • Assist in executing other component manufacturing equipment/process validations and author validation protocols/reports as needed.
  • Perform statistical data analysis using Minitab and Distribution Analyzer as needed.
  • Compile executed validation packages.
  • Perform revalidation and change control validation-related activities.
  • Perform and assist in any validation activities but not limited to: SOP, Work instruction, forms, templates.
  • Lead and write deviation investigations related to validations or assist in non-conformances/CAPA investigations.
  • Participate in project discussion sessions as a validation representative with the client for new products or changes in existing processes.
  • Author validation assessments for adoption into the existing validation brackets.
  • Perform validation documentation reviews using Document management systems such as Documentum and change order assessments in SAP and Agile.
  • Bachelor's degree in engineering, life sciences, or a related field.
  • Proven experience in quality assurance or a related role in the medical device industry.
  • Strong knowledge of quality management systems, regulatory requirements (e.g., CE, FDA, ISO 13485), and relevant industry standards.
  • Experience in laser marking, laser welding, passivation, and injection molding processes.
  • Solid understanding of manufacturing processes, quality control methods, and statistical techniques.
  • Experience in conducting root cause analysis, risk assessments, and implementing corrective and preventive actions (CAPAs).
  • Excellent problem-solving skills and the ability to analyze complex situations and make sound decisions.
  • Strong organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.
  • Excellent communication skills, both written and verbal, with the ability to effectively communicate with cross-functional teams.
  • VTI offers professional development, training, competitive compensation, excellent benefits, a matching 401K, plus a stimulating and collaborative work environment.
  • We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.
  • As one of the leading global Commissioning, Qualification and Validation Services organizations, VTI is always looking for innovative, talented and experienced validation professionals for our multinational and global offices.
  • We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees.
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