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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.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in preparing and reviewing technical documentation for mechanical systems, ensuring compliance with GMP and GEP standards. Possesses strong communication skills in Danish and English, facilitating effective stakeholder engagement and advising on mechanical solutions.
Highest-signal resume keywords
Mechanical Systems ExpertiseGMP ComplianceTechnical Documentation PreparationMachine Safety KnowledgeStakeholder Communication
ATS Keywords
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Hard Skills
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
Industry Keywords
Pharmaceutical IndustryEngineering ConsultancyATEXGEP PrinciplesQuality RequirementsRegulatory Expectations
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