Senior Mechanical Engineer, Quality and Documentation

Jobtailor; Kalundborg; On-site; DKK 900,000 - 1,200,000; Full time

Job summary

Jobtailor in Kalundborg, Denmark, seeks an experienced mechanical systems and quality documentation professional for pharma projects. You will prepare and review technical and quality docs, develop URS, Design Specs, and RTMs, and ensure alignment with GMP standards.

You will review P&IDs, layouts, and drawings; perform line walks to verify installations; participate in FAT/SAT, commissioning, qualification and validation.

Qualifications

• 10+ years with mechanical systems and quality documentation in pharma projects.
• Experience with machine safety, ATEX, and process equipment.
• Strong GMP and GEP knowledge and application.
• High technical expertise and professional integrity.
• Experience from engineering consultancy is a plus.
• Fluent Danish and English for documentation and stakeholder communication.

Responsibilities

• Prepare and review technical and quality documentation for mechanical systems.
• Develop URS, Design Specs, Technical Specs, and RTMs.
• Review P&IDs, layouts, and mechanical drawings.
• Perform line walks and verify installations against requirements.
• Participate in FAT, SAT, commissioning, qualification, and validation.
• Review design docs, component lists, welding docs, certificates.
• Ensure GMP and applicable quality standards compliance.
• Advise clients on mechanical solutions, machine safety, regulatory expectations.
• Build relationships with clients, suppliers and stakeholders.

Skills

Mechanical systems

Quality documentation

URS & Specs

P&ID review

GMP/GEP

Client communication

Danish & English

Job description

• 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

• 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.