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 supply complete aseptic filling lines and offer a portfolio that 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
* Control and plan all mechanical resources dedicated to own projects.
* Make technical decisions within project scope.
* Report new technical ideas identified during a project.
* Lead and promote strategic initiatives to help the team achieve safety, quality, delivery, and cost goals of the projects.
* Follow mechanical engineering standard designs and drawing standards.
* Lead mechanical design of projects.
* Ensure projects meet functional and customer requirements (URS, FS).
* Coordinate with other departments.
* Create, monitor, and validate project documentation.
* Lead internal design reviews, risk analysis (FMEA), and validation activities.
* Ensure on‑time delivery, budget, and quality requirements.
* Apply regulatory standards such as GMP, FDA, EMA and ISO.
* Ensure smooth integration between mechanical systems and software, electrical, and process teams.
* Maintain full traceability of design modifications.
* Collaborate with Quality department on documentation and validation compliance (DQ/IQ/OQ/PQ).
* Lead mechanical reviews, client‑facing stages, FAT, SAT, and commissioning.
* Promote continuous improvement by identifying opportunities for innovation and standardisation.
* Manage documentation modifications.
Main Tasks
* Plan, cost and quality monitoring (project mechanical design phase).
* Support assembly technicians during machine assembly on workshop.
* Decide on design non‑conformities or incidence resolution.
* Complete mechanical engineering checklist.
* Review and approve project documentation; create documentation when required.
* Define and agree technical purchase specifications with suppliers.
* Coordinate inter‑departmental projects with Purchasing, Project Management, Electrical Engineering, Software, Service and Production.
* Coordinate internal and external mechanical resources; assign tasks.
* Promote technical guideline creation.
* Conduct technical studies and calculations.
* Create machine and installation layouts.
* Support applications department on new project offers (layouts, conceptual design).
* Define machine architecture (mechanisms, motion systems, commercial components, etc.).
* Produce 3D CAD models, detailed drawings, and bills of materials using SolidWorks and ERP tools.
* Create and maintain detailed mechanical project plans, deliverables, and milestones.
* Review and release technical documentation including 3D CAD models, 2D drawings and BOMs.
* Release mechanical parts and assemblies to purchasing department.
* Lead and manage engineering change orders within mechanical design scope (COR’s).
* Validate mechanical designs for functionality, manufacturability, serviceability, and compliance.
* Define technical characteristics of special subassemblies.
* Other unspecified tasks linked to business operation.
Professional Experience
* 5 years’ experience in machinery design, preferably for the pharmaceutical sector.
* Expertise in aseptic fill & finish, RABS, isolators, and classified cleanroom environments (ISO 5, ISO 7).
* Knowledge of CIP/SIP systems, laminar flow integration, and contamination control principles.
* 5 years’ experience in a 3D design environment; proficiency in SolidWorks.
* Proficiency in DraftSight and AutoCAD.
* Familiarity with Office solutions and MS Project.
* Experience 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 organise 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 standards.
* Familiar with GMP, FDA, and GAMP5 requirements.
* Availability to travel (0–10% of the time).
* B2 English level.
GDPR
By applying for this role, you give permission for SP to use and store your personal information contained within your CV or any other relevant information you provide to review your application for the specific role applied for. We will process this data for recruitment purposes only, which may include being sent to the US for review and further processing. We will not disclose your information to any third party unless legally required to do so.
We would like to keep this data until our open role is filled. When that period is over, we will archive the information which will then be deleted annually.
Health & Safety
All employees have the responsibility to work in a safe manner and report any health, safety or environmental concern to their manager or supervisor in a timely manner.
Employee responsibilities for Health, Safety and Environment include:
* Work in compliance with divisional health, safety and environmental procedures.
* Refrain from removing or altering safety devices or guarding unless hazardous energies are controlled through lockout‑tagout methods.
* Report any unsafe conditions or unsafe acts.
* Report defects in any equipment or protective device.
* Ensure that the required protective equipment is used for the assigned tasks.
* Attend all required health, safety and environmental training.
* Report any accidents/incidents to supervisor.
* Assist in investigating accidents/incidents.
* Refrain from engaging in any prank, contest, feat of strength, unnecessary running or rough and boisterous conduct.
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Engineering and Information Technology
Industries: Industrial Machinery Manufacturing
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