Validation Engineer – Quality (medical industry)

BEPC Inc. - Business Excellence Professional Consulting; Ciudad Juárez; Presencial; MXN 480.000 - 700.000; Jornada completa

Descripción de la vacante

BEPC Inc. in Mexico seeks a Validation Engineer - Quality to execute and support validation activities in regulated medical device manufacturing environments.

You will lead IQ/OQ/PQ protocols, CSV and TMV efforts, and contribute to MVP/MVI/SVMP lifecycle management. Collaborating with Engineering, Manufacturing, Quality, R&D and Regulatory teams, you will ensure compliance with FDA, ISO 13485, GMP and GDP, maintain QA documentation, and drive risk-based validation and continuous improvement

Formación

• Bachelor's Degree in Engineering or related technical field.
• 3-5 years of experience in validation, quality/ manufacturing engineering or related activities in a regulated environment.
• Practical experience with IQ/OQ/PQ execution and documentation.
• Familiarity with FDA regulations (21 CFR Part 820), ISO 13485, GMP, GDP, and QMS.
• Experience with CSV and TMV validations and knowledge of MVP/MVI/SVMP lifecycle.
• Knowledge of risk-based validation methodologies and DOE with statistical analysis.
• Experience supporting CAPA, deviations, non-conformances, and change control.
• Familiarity with calibration documentation and Lean Six Sigma, DMAIC concepts.
• Strong technical writing, communication, organization and presentation skills.
• Advanced English proficiency, written and verbal.

Responsabilidades

• Execute and support validation activities for manufacturing processes, equipment, test methods, and computerized systems.
• Write, review, and execute OQ, PQ, CSV, TMV, FAT and SAT protocols and reports.
• Support MVP, MVI, and SVMP documentation and validation lifecycle management.
• Develop validation documentation in accordance with FDA, ISO 13485, GMP, GDP and QMS.
• Collaborate with cross-functional teams (Engineering, Manufacturing, Quality, R&D, Regulatory).
• Apply risk-based validation approaches and participate in risk assessments and DOE activities.
• Support audits and regulatory inspections; assist in deviation investigations and CAPAs.

Conocimientos

Quality engineering

Validation

Technical writing

Project management

Lean Six Sigma

Educación

Bachelor's Degree in Engineering

Herramientas

CSV

TMV

DOE

Descripción del empleo

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.

We are seeking a Validation Engineer - Quality to execute and support validation activities within regulated medical device manufacturing environments. This role will support process, equipment, test method, and computerized system validations, including the development and execution of IQ/OQ/PQ protocols, Computer Systems Validation (CSV), and Test Method Validation (TMV) activities.

The Validation Engineer III will work cross-functionally with Engineering, Manufacturing, Quality, R&D, and Regulatory teams to ensure validation activities comply with FDA regulations, ISO 13485, GMP, GDP, and internal Quality Management System (QMS) requirements.

KEY RESPONSIBILITIES:

• Execute and support validation activities for manufacturing processes, equipment, test methods, and computerized systems.
• Write, review, and execute:
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Computer Systems Validation (CSV)
  • Test Method Validation (TMV)
  • Factory Acceptance Testing (FAT)
  • Site Acceptance Testing (SAT)
• Support the maintenance and execution of validation activities associated with the Master Validation Plan (MVP), Master Validation Index (MVI), and Site Validation Master Plan (SVMP).
• Develop validation protocols, reports, forms, and supporting technical documentation in accordance with FDA, ISO 13485, GMP, GDP, and QMS requirements.
• Support the design and execution of Design of Experiments (DOE) and statistical analysis for validation activities.
• Participate in pre-validation activities, including risk assessments, feasibility studies, and experimental runs.
• Coordinate validation deliverables to ensure completion according to project timelines and regulatory requirements.
• Provide technical support during internal/external audits and regulatory inspections.
• Support and participate in deviation investigations, CAPAs, non-conformance investigations, and change control activities.
• Apply risk-based validation approaches to determine appropriate validation strategies and testing requirements.
• Support the creation and maintenance of calibration and preventive maintenance records in accordance with QMS requirements.
• Collaborate cross-functionally with Manufacturing, Quality, R&D, Engineering, and Regulatory Affairs.
• Apply Lean Manufacturing, Six Sigma/DMAIC, and continuous improvement methodologies to improve validation efficiency and process robustness.
• Prepare validation data and documentation required for validation closure reports.
• Ensure validation activities and documentation comply with applicable Good Documentation Practices (GDP).

MAIN QUALIFICATIONS:

• Bachelor's Degree in Engineering or a related technical field.
• Approximately 3-5 years of experience in validation, quality engineering, manufacturing engineering, or related activities, preferably within the medical device industry or another regulated manufacturing
• Practical experience with IQ/OQ/PQ execution and documentation.
  • FDA regulations / 21 CFR Part 820
  • ISO 13485
  • GMP
  • GDP
  • Quality Management Systems (QMS)
• Experience or working knowledge of CSV and TMV validations.
• Familiarity with MVP, MVI, and SVMP documentation and validation lifecycle management.
• Knowledge of risk-based validation methodologies.
• Working knowledge of DOE and statistical analysis.
• Experience supporting CAPA, deviations, non-conformances, and change control.
• Familiarity with calibration and preventive maintenance documentation.
• Knowledge of Lean Manufacturing, Six Sigma, DMAIC, and continuous improvement methodologies.
• Working knowledge of project management principles.
• Strong technical writing and documentation skills.
• Advanced English proficiency, written and verbal.
• Strong communication, organization, collaboration, and presentation skills.