PM Mechanical Engineer

PharmEng / Efor is a leading pharmaceutical and biopharmaceutical consulting company committed to providing innovative solutions to the challenges facing our industries. We pride ourselves on our dedication to quality, safety, and excellence in everything we do. As we continue to grow, we are looking for a highly qualified and motivated Mechanical Engineer to join our team.

Position Title: Mechanical Engineer PMO

Location: Madrid

Type of Contract: Full-Time

Position Summary

The Mechanical Engineer is responsible for managing the full lifecycle of technical specifications (URS) and design documentation for critical equipment and utility systems. This includes coordinating weekly meetings with vendors and cross-functional teams, reviewing and approving technical documents (FS, SDS, HDS, schematics), and ensuring alignment with project milestones and quality standards. The role involves supervising layout modifications, utility connections, and equipment logistics, while maintaining strict budget control and contractor access compliance. 

Project Responsibilities 

• On-site presence at site offices for direct coordination with internal and external teams.
• Management of the URS (User Requirement Specification) for utilities: drafting, reviewing, incorporating comments, and overseeing final approval within the internal system.
• Attendance at weekly meetings with selected vendors to resolve technical queries.
• Participation in weekly project team meetings, including agenda preparation, minute taking, and action tracking.
• Review and oversight of the proposed equipment design, including all associated documentation (FS, SDS, HDS, electrical and pneumatic schematics), and coordination of its review, commenting, updates, and approval within internal documentation systems.
• Evaluation and review of the impacted utility designs and their connection to building infrastructure (drainage and venting systems).
• Coordination and agreement on optimal technical solutions for required layout modifications.
• Coordination and agreement on the best technical approach for equipment entry and movement logistics.
• Financial oversight of the project, including detailed tracking of purchase orders and expenditures.
• Management of contractor site access and safety inductions, in collaboration with the HSE department, for activities including:
  • Equipment installation
  • Layout modifications
  • Utility works
  • Other related tasks
• Technical support in the development of sterilization cycle studies with the selected equipment manufacturer.
• On-site supervision of construction activities and active participation in walkdowns alongside the Site Manager or Construction Manager.
• Management of commissioning activities for applicable systems (including protocol development and testing), in collaboration with the CQV department, covering:
  • Clean steam
  • Process air
  • Other systems
• Documentation management:
  • Updating and uploading of drawings, P&IDs, and GAs in Pdocs
  • Monitoring project schedule and milestone achievement
• FAT (Factory Acceptance Test) coordination:
  • Review of FAT protocol
  • Attendance at FAT and management of deviations categorized as CAT 1, 2, and 3

Qualifications

• Mechanical Engineer.
• Minimum years of experience in pharmaceutical projects.
• Strong knowledge of GMP, GDP, and regulatory guidelines (FDA, EMA, WHO).
• Proficient in writing technical documentation and validation protocol and reports.
• Excellent communication, analytical, and project management skills.
• Fluent in English (written and spoken); other languages are a plus.

Preferred Skills

• Experience with FDA and EMA compliance.
• Familiarity with validation software tools and electronic documentation systems.
• Knowledge of data integrity principles and ALCOA+ framework.
• Systemic vision, strong analytical skills, and attention to detail.
• Results-oriented.
• Ability to manage multiple projects and prioritize tasks effectively.
• Excellent communication and negotiation skills (synthesis and presentation of ideas).
• Ability to collaborate effectively with cross-functional teams.
• Adaptability: Ability to thrive in a dynamic and fast-paced environment.

What We Offer

• Competitive salary.
• Opportunities for professional development and training.
• Dynamic and collaborative work environment.
• Contribution to high-impact pharmaceutical projects.

Join us: If you are a dedicated and highly motivated individual with a passion for ensuring the highest standards of Engineering and Quality in the Pharmaceutical Industry, we encourage you to apply. PharmEng / Efor offers a dynamic and inclusive work environment, competitive compensation, and opportunities for professional growth. Be part of our team and contribute to the success of our industry-leading solutions.

PharmEng / Efor is an equal opportunity employer and welcomes applicants from all backgrounds.

Thank you for your consideration and application We review all resumes and submissions, however, due to the high volume of applications we receive, only approved candidates will be contacted.