CQV Engineer for Projects

Description

Position Summary: We are seeking a CQV engineer for a pharmaceutical project, responsible for planning, executing, and documenting validations, ensuring regulatory compliance and high quality standards. Key Highlights: 1. Experience in Commissioning, Qualification & Validation (CQV) 2. Work with HVAC systems, utilities, and process equipment 3. Engineering degree and GMP knowledge An engineer with experience in Commissioning, Qualification & Validation (CQV) is required to participate in a major pharmaceutical project. Candidates must have at least one year of CQV experience and be willing to integrate into a stimulating professional environment. Responsibilities include planning, executing, and maintaining detailed records of validation and commissioning activities. The objective is to ensure that equipment and systems strictly comply with GMP regulations and the highest quality standards. Work will involve diverse systems including HVAC, utilities (PW, WFI, gases), and process equipment. Proficiency with automated systems and knowledge of computerized system validation (CSV) are considered advantageous. A university degree in engineering (Industrial, Chemical, Mechanical, Electrical, or Biomedical) is required. A Master’s degree or additional training in Validation and Quality is preferred. Candidates must be able to apply GMP regulations and regulatory guidelines, implement risk-based validation methodologies, and draft and review technical documentation and CQV protocols. High-level Spanish and professional-level English (for technical reading and writing) are required. Bachelor’s degree in Engineering (Industrial, Chemical, Mechanical, Electrical, Biomedical, or related field). Minimum 1 year of CQV experience in regulated environments. Experience with HVAC systems, utilities (PW, WFI, gases), and process equipment. Knowledge of GMP regulations and regulatory guidelines. Risk-based validation methodology. Ability to develop technical documentation and CQV protocols. Professional-level English (technical reading and writing).