Quality mechanical engineers

Our cliente is recruiting several a Quality Mechanical Engineers for Dennmark to participate on the beggining of a new factory on industrial farmaceutic sector. key responsibilitiesEnsure that mechanical systems (HVAC, cleanroom ventilation, piping, etc.) are designed and installed in compliance with GMP, FDA, and other pharmaceutical industry standards.Perform quality reviews and inspections of mechanical installations throughout the construction process, identifying and addressing potential non-conformities.Collaborate with engineering, construction, and validation teams to ensure mechanical designs meet all regulatory and project-specific quality requirements.Develop and review technical documentation, including design specifications, quality control procedures, and validation protocols for mechanical systems.Conduct risk assessments, root cause analysis, and corrective/preventive actions (CAPA) to address quality issues in mechanical systems.Support the commissioning, qualification, and validation (CQV) processes for mechanical equipment and systems in pharmaceutical facilities.Ensure that all mechanical systems comply with safety regulations, environmental standards, and cleanliness requirements specific to pharmaceutical production environments.Prepare reports and documentation for internal audits, client reviews, and regulatory inspections.Oversee the quality control of materials and components used in mechanical systems, ensuring they meet project specifications and standards.Coordinate with external contractors and suppliers to ensure compliance with mechanical system quality requirements.Contribute to continuous improvement initiatives aimed at enhancing the quality of mechanical engineering processes in pharmaceutical projects.Experience from Quality work within stainless steel is a plus.skillsBachelor’s or Master’s degree in Mechanical Engineering or related field.5+ years of experience in mechanical quality assurance, preferably within the pharmaceutical or biotech construction industry.Strong knowledge of GMP, FDA, EMA, and other regulatory standards for pharmaceutical facilities.Familiarity with HVAC, piping, cleanroom systems, and other critical mechanical systems used in pharmaceutical environments.Experience with quality control processes, CAPA, root cause analysis, and risk assessments.Proficiency in quality management systems and tools for documenting, tracking, and reporting quality issues.Strong problem-solving skills and a detail-oriented approach to quality assurance.Excellent communication skills and the ability to work collaboratively across multidisciplinary teams.Ability to manage multiple tasks and prioritize effectively in a fast-paced environment.