CSV Specialist

MENTOR TECHNICAL GROUP; Barceloneta (PR); Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

Mentor Technical Group seeks an experienced BAS Validation Engineer to support qualification and validation activities for Building Automation Systems, HVAC, environmental monitoring, and GMP facility infrastructure. The role includes validating systems like Siemens Desigo CC and ensuring compliance with FDA regulations, GAMP 5, data integrity, and site quality procedures.

You will author IQ/OQ/PQ protocols, develop validation plans, URS, risk assessments, and traceability matrices, and

Formación

• Bachelor's degree in engineering, life sciences, or related field.
• 3+ years in validation, commissioning & qualification in GMP environments.
• Experience executing IQ/OQ/PQ protocols; knowledge of BAS/BMS, HVAC, GAMP 5, FDA regulations.

Responsabilidades

• Develop and execute IQ, OQ, and PQ protocols.
• Author and review validation documents (Plans, URS, Risk Assessments, Traceability, VSR).
• Validate BAS/BMS and HVAC systems; support change controls, deviations, CAPA.

Conocimientos

Documentation

Technical writing

Collaboration

Regulatory compliance

Educación

Bachelor's degree

Herramientas

Siemens Desigo CC

IQ/OQ/PQ protocols

Descripción del empleo

Mentor Technical Group (MTG) is seeking an experienced BAS Validation Engineer to support qualification and validation activities for Building Automation Systems (BAS), HVAC systems, environmental monitoring systems, and GMP facility infrastructure.

The selected candidate will support the validation lifecycle of systems such as Siemens Desigo CC, ensuring compliance with FDA regulations, GAMP 5 methodologies, Data Integrity requirements, and site quality procedures.

Key Responsibilities

• Develop and execute IQ, OQ, and PQ protocols.
• Author and review validation documents, including:
  • Validation Plans
  • URS
  • Risk Assessments
  • Traceability Matrices
  • Validation Summary Reports (VSR)
• Validate BAS/BMS and HVAC systems, including alarms, trends, controllers, sensors, and field devices.
• Support change controls, deviations, discrepancies, and CAPA activities.
• Verify compliance with 21 CFR Parts 11, 210, and 211, GAMP 5, and Data Integrity requirements.
• Collaborate with Engineering, Facilities, Automation, Validation, and Quality teams.
• Support regulatory inspections and audit readiness activities.

Minimum Qualifications

• Bachelor's Degree in Engineering, Life Sciences, or related discipline.
• 3+ years of experience in Validation, Commissioning & Qualification (C&Q), Automation, or CSV within a GMP-regulated environment.
• Experience executing IQ/OQ/PQ protocols.
• Knowledge of:
  • Building Automation Systems (BAS/BMS)
  • HVAC Systems
  • GAMP 5
  • FDA Regulations
  • Data Integrity Principles
• Strong technical writing and documentation skills.

Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.

Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.