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Senior Mechanical Engineer, Quality and Documentation
NorconsultMechanical Engineer role at Norconsult Danmark focusing on quality and documentation within the pharmaceutical industry. Exciting opportunity with a leading engineering consultancy in the Nordic region.
About the role
Key responsibilities & impact- Preparing and reviewing technical and quality related documentation for mechanical systems and process equipment.
- Developing User Requirements Specifications (URS), Design Specifications, Technical Specifications, and Requirements Traceability Matrices (RTMs).
- Reviewing P&IDs, layouts, technical drawings, and mechanical documentation.
- Performing line walks and verifying installations against design requirements and GMP standards.
- Participating in FAT, SAT, commissioning, qualification, and validation activities.
- Reviewing design documentation, including component lists, instrument lists, welding documentation, material certificates, and technical specifications.
- Ensuring compliance with GMP requirements, applicable quality standards, and relevant industry regulations.
- Advising clients on mechanical solutions, machine safety, quality requirements, and regulatory expectations.
- Building and maintaining strong relationships with clients, suppliers, and other stakeholders.
Requirements
What you’ll need- A minimum of 10 years of experience working with mechanical systems, quality and documentation in pharmaceutical industry projects.
- Experience with machine safety, ATEX and various types of process equipment.
- Solid knowledge of GMP and GEP principles and requirements.
- A high level of technical expertise and professional integrity.
- Experience from the engineering consultancy industry is considered an advantage.
- Strong written and verbal communication skills in both Danish and English, enabling you to prepare technical documentation, reports and communicate effectively with stakeholders.
Benefits
Comp & perks- We offer a competitive benefits package in line with industry standards
- Pension scheme
- Health insurance
- Opportunities for continuous professional development and training
ATS Keywords
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Hard Skills & Tools
User Requirements SpecificationsDesign SpecificationsRequirements Traceability MatricesP&ID ReviewTechnical Drawing ReviewCommissioning and QualificationValidation ActivitiesWelding Documentation ReviewMaterial Certificates ReviewQuality Standards Compliance
Soft Skills
Strong Written CommunicationStrong Verbal CommunicationClient Relationship Management