Quality Mechanical Engineer- Kalundborg, Denmark: Minimum 37 hours a week
We are currently looking for a Quality Mechanical Engineer for a Pharmaceutical Project based in Kalundborg, Denmark.
We can pay 68 euros per hour, PAYE
Duties:
- 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.
Give Harry a call on 0191 249 8098 if interested for more information.
Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.
Candidates must be eligible to live and work in the UK.
For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
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