Mechanical Engineering Project Leader

Job Description

Comecer Barcelona, an ATS Company, is a leading company in the design and development of machinery for the pharmaceutical sector. We are one of the few companies worldwide with the capability to supply complete aseptic filling lines. Our portfolio includes washers, tunnels, dosing systems, capping machines, and loading systems. For our factory in Mataró, we are looking for a Mechanical Engineering Project Leader to join our technical office.

Roles and responsibilities

1. Control and plan all mechanical resources dedicated to own projects.
2. Technical decisions taking within project scope.
3. Report the new technical ideas identified during a project.
4. Lead and promote strategic initiatives to help the team achieve the safety, quality, delivery, and cost goals of the projects.
5. Follow mechanical engineering standard designs.
6. Work towards annual individual (and team) objectives.
7. Use drawing standards.
8. Leading mechanical design of projects.
9. Ensure projects meet functional and customer requirements (URS, FS).
10. Coordination with other departments.
11. Project documentation creation, monitoring and validation.
12. Lead internal design reviews, risk analysis (FMEA), and validation activities.
13. Ensure OTD, budget and quality requirements.
14. Follow regulatory standards such as: GMP, FDA, EMA and ISO.
15. Ensure smooth integration between mechanical systems and software, electrical, and process teams.
16. Ensure full traceability of design modifications.
17. Lead the Documentation Analyst role on collaboration with Quality department to ensure compliance with validation and documentation standards (DQ/IQ/OQ/PQ).
18. Lead mechanical reviews, client-facing stages, FAT, SAT, and commissioning.
19. Promote continuous improvement by identifying opportunities for innovation and standardization within the mechanical design domain
20. Manage documentation modifications

Main Tasks

1. Planning, cost and quality monitoring (delimited to project mechanical design phase).
2. Support assembly technicians during machines assembly on workshop.
3. Decision making on design non-conformities or incidences resolution
4. Mechanical engineering checklist completion.
5. Project documentation revision and approval (eventually documentation creation).
6. Definition and agreement of technical purchase specifications with suppliers.
7. Inter-departmental project coordination with Purchasing, Project Management, Electrical engineering, Software, Service and Production.
8. Coordinate internal and external mechanical resources. Task assignment included.
9. Promote technical guidelines creation.
10. Technical studies and calculations.
11. Machine and installation layouts creation.
12. Support applications department when discussing new projects offers (layouts, conceptual design, etc).
13. Define machine architecture (mechanisms, motion systems, commercial components, etc).
14. Produce 3D CAD models, detailed drawings, and bills of materials using 3D Tools (SolidWorks) and ERP Tools.
15. Create and maintain detailed mechanical project plans, deliverables, and milestones.
16. Review and release technical documentation including 3D CAD models, 2D drawings and BOMs.
17. Release mechanical parts and assemblies to purchasing department.
18. Lead and manage engineering change orders within mechanical design scope (COR's).
19. Validate mechanical designs for functionality, manufacturability, serviceability, and compliance.
20. Technical characteristics definitions of special subassemblies.
21. Other unspecified tasks linked with business operation

Additional Information

Professional Experience

• 5 years’ experience in machinery design, preferably for the pharmaceutical sector.
• Aseptic Fill & Finish and aseptic technologies expertise such as RABS, isolators, and classified cleanroom environments (ISO 5, ISO 7) is highly valued.
• CIP/SIP systems, laminar flow integration, and contamination control principles knowledge is a plus.
• 3D Skills: 5 years' experience in 3D design environment. Proficiency in 3D CAD software (SolidWorks preferred).
• 2D skills: Proficiency in Draftsight and AutoCAD.
• Used to work with Office solutions and MS Project.
• Experience working with documentation systems (PLM/ERP) and ECR/ECN workflows.

Skills and abilities

• Autonomy.
• Leadership.
• Proactivity.
• Team-orientation and detail-focus.
• Problem-solving mindset.
• Ability to organize and plan.
• Project management.
• Excellent communication skills — able to interface with clients, suppliers, and internal stakeholders.
• Strong understanding of machine design, motion systems, pneumatics, robotics, and precision mechanics.
• Materials knowledge, surface finishes and mechanical std’s.
• Familiar with GMP, FDA, and GAMP5 requirements.
• Availability to travel (0-10% of the time).
• B2 English level.