Validation Engineer (DAYTON)

Validation Engineer
Dayton, OH                                       

POSITION SUMMARY:
 
Our client is a premier chassis supplier that designs and manufactures brake and suspension systems for the global transportation market.  BWI Group is seeking a Validation Engineer who is responsible for planning, executing, and documenting validation activities for equipment, systems, and manufacturing processes to ensure compliance with internal requirements and external regulatory or customer standards. This role develops validation protocols, conducts tests, analyzes results, and partners with engineering, quality, and operations to maintain validated states and support audits.

JOB RESPONSIBILITIES:
 

  • Establish validation and qualification criteria for equipment, utilities, processes, or computer systems based on specifications and regulatory requirements.
  • Develop, review, and execute validation master plans and protocols (for example IQ, OQ, PQ, FAT, SAT, test plans, and traceability).
  • Create and run tests to evaluate system performance, capability, and repeatability against approved protocols.
  • Calibrate, verify, and oversee maintenance of instruments and equipment used in validation activities.
  • Analyze test data using appropriate statistical methods and summarize results in validation reports with clear conclusions and recommendations.
  • Identify deviations, nonconformances, and risks; lead or support root cause investigations and implementation of corrective and preventive actions (CAPA).
  • Maintain validation documentation including protocols, reports, risk assessments, traceability matrices, and activity logs in accordance with quality system requirements.
  • Ensure systems remain in a validated state through periodic review, revalidation, and change control support.
  • Collaborate with engineering, quality, manufacturing, IT, and suppliers during design, commissioning, and qualification of new or modified equipment and processes.
  • Support internal and external audits or inspections by providing validation documentation and subject?matter expertise.
  • Train or mentor technicians and junior team members on validation procedures, test methods, and documentation practices as needed.
  • Ensure validation activities comply with applicable regulations and standards (for example FDA, GMP, ISO 13485, and relevant product standards).

REQUIREMENT QUALIFICATIONS:
 

  • Bachelor’s degree in Mechanical, Electrical, Chemical, Biomedical, or related Engineering or a closely related scientific field.
  • Experience in validation, test, quality, or process engineering in a manufacturing or laboratory environment (internships or co?ops for entry level).
  • Strong understanding of manufacturing processes, quality systems, and applicable safety or regulatory requirements.
  • Ability to develop and execute validation protocols, analyze technical data, and write clear technical reports.
  • Knowledge of statistical analysis tools or software (for example, MATLAB, Minitab, or similar).
  • Excellent attention to detail, organizational skills, and ability to manage multiple validation activities and deadlines.
  • Effective communication and teamwork skills to work across engineering, quality, and operations teams.

PREFERRED QUALIFICATIONS:
 

  • Experience in a regulated industry such as pharmaceuticals, biotechnology, medical devices, or automotive safety systems.
  • Familiarity with computer system validation (CSV) and 21 CFR Part 11 or equivalent guidelines, where applicable.
  • Working knowledge of relevant standards and regulations (for example FDA, GMP, ISO 9001, ISO 13485, and sector?specific standards).
  • Experience with risk management tools (FMEA, risk matrices) and structured problem?solving methodologies such as Six Sigma or Lean.
  • Project management capability, including planning validation activities, coordinating cross?functional resources, and tracking progress.