Our client is recruiting a Quality Mechanical Engineers for Dennmark to participate on the beggining of a new pharmaceutical plant.
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quality mechanical engineers.
- dinamarca
- posted 7 days ago
- closes 5 december 2024
key responsibilities
- Ensure 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.
skills
- Bachelor’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.
the application process.
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