Software Validation Engineer

hace 16 horas

Juárez, Chihuahua, México BEPC Inc. - Business Excellence Professional Consulting A tiempo completo

BEPC Inc. provides Specialized Engineering Solutions and IT Project Management services to Fortune 500 companies in the Life Science and Technology industries. BEPC Mexico, a division of BEPC Incorporated, provides and manages consulting services for Automotive and Medical device companies throughout Mexico and around the globe.

The
Computer Software Validation Senior Engineer
works closely with Production, Engineering, and Quality teams to ensure that new, existing, and transferred manufacturing processes and embedded software are properly validated and documented in compliance with internal procedures and applicable regulatory requirements.

This role supports New Product Introduction (NPI) and continuous improvement initiatives, contributing to the resolution of quality, productivity, and compliance issues within a regulated manufacturing environment.

KEY RESPONSABILITIES:

  • Validate new, current, and transferred processes, machinery, products, and software embedded within manufacturing processes to ensure they meet defined requirements and intended use.
  • Perform Computer Software Validation (CSV) activities through rigorous testing, risk analysis, and documentation.
  • Develop validation strategies, test plans, and protocols for software and automated systems.
  • Execute validation protocols (IQ/OQ/PQ as applicable) and document results in accordance with company and regulatory standards.
  • Identify software defects, document issues, and collaborate with development and automation teams to ensure timely resolution prior to release.
  • Maintain and update process documentation, including setup sheets, manufacturing guidelines, SOPs, and validation reports.
  • Coordinate and support the implementation of new products, equipment, processes, and software systems.
  • Support Lean Manufacturing initiatives and continuous improvement projects focused on quality, productivity, and cost reduction.
  • Assist in the investigation and resolution of internal and external quality issues, including deviations, CAPAs, and audit findings.
  • Support new product and process development activities from a validation and compliance perspective.
  • Provide training to engineering, manufacturing, and quality personnel on validation principles, new processes, and documentation requirements.

QUALIFICATIONS:

  • Bachelor's degree in manufacturing, engineering or related field.
  • Minimum 3 years' experience high volume manufacturing injection molding manufacturing.
  • Medical device manufacturing experience (must).
  • Experience in Process Validations (NPI, Processes, Machinery)
  • Experience in Software validation, preferred in automation lines
  • Proficiency with testing software, debugging tools, and databases.
  • Understanding software development lifecycles.
  • Knowledge of Medical Industry Regulations. (CFR 21 part 11, Annex 11 of EC, ISO
  • Good analytic and problem-solving skills.
  • Ability to interpret and analyze technical products, assembly and tooling drawings
  • Advanced English proficiency

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