Engineering & Design Lead

Posted 2 Days Ago
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Añasco, PRI
In-Office
Entry level
Pharmaceutical
The Role
Leads multidisciplinary engineering and design coordination for pharmaceutical and medical-device capital projects. Supports project scoping, feasibility, Basis of Design, construction documentation, design reviews, compliance tracking, risk and issue resolution, and construction execution. Coordinates architects, engineers, vendors, project managers, and construction teams while ensuring cGMP, GEP, safety, sustainability, constructability, operability, and maintainability requirements are met.
Summary Generated by Built In

 For Engineering & Design (E&D) Lead services in the Capital Projects/Site Engineering area.

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor's Degree in Engineering, Architecture, Construction Management, or a related technical discipline and previous experience within the Pharmaceutical or Medical Devices industry. 
  • Fully Bilingual (Spanish & English) 
  • Shift: Administrative & according to business needs 
  • Proficiency with Teams, SharePoint, OneNote, Bluebeam, Autodesk/ACC, or comparable design and document-management platforms.
  • Experience in:
    • Leading multidisciplinary engineering and design activities for capital projects in regulated manufacturing environments.
    • cGMP/GEP, engineering design standards, NFPA, applicable ASME standards, and building/permitting requirements.
    • Coordinating design deliverables from early scope and BOD development through construction documentation and execution support.
    • Managing design reviews, compliance trackers, action/decision/risk logs, and cross-functional issue closure.

The Personality Part:    

  • Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

  • Provide E&D Lead support for a portfolio of capital, facility, infrastructure, and manufacturing projects at the Añasco site.
  • Lead multidisciplinary design coordination across architectural, civil, structural, mechanical/HVAC, process utilities, electrical, automation, fire protection, IT/OT, and related disciplines.
  • Support early project definition, including scoping, URB, feasibility studies, concept development, and capital planning activities.
  • Coordinate AE RFP development and provide governance through Basis of Design (BOD), construction documents, and design execution.
  • Lead design reviews and ensure alignment with cGMP/GEP requirements, engineering standards, SDPs, and applicable IDEA deliverables.
  • Maintain an integrated design governance tracker covering deliverables, actions, decisions, risks, design gaps, and issue closure.
  • Assess project readiness and identify gaps in URB, Concept, BOD, and other design-development stages.
  • Coordinate design interfaces among project management, site stakeholders, engineering disciplines, AE partners, vendors, and construction teams.
  • Support projects involving manufacturing relocations, automation, process equipment, utilities, infrastructure, and facility-condition improvements.
  • Ensure designs consider material, personnel, and waste flows as well as constructability, operability, maintainability, EHS, and sustainability requirements.
  • Monitor SDP compliance and tailor IDEA deliverables according to applicable Alpha, Beta, or Gamma project requirements.
  • Provide design-related construction support, technical issue resolution, document coordination, and review-by-exception throughout project execution.

WHO WE ARE:

We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! 

Are you the next piece?

Skills Required

  • Bachelor’s degree in engineering, architecture, construction management, or a related technical discipline
  • Previous experience in the pharmaceutical or medical devices industry
  • Fully bilingual in Spanish and English
  • Proficiency with Teams, SharePoint, OneNote, Bluebeam, Autodesk Construction Cloud, or comparable design and document-management platforms
  • Experience leading multidisciplinary engineering and design activities for capital projects in regulated manufacturing environments
  • Knowledge of cGMP, GEP, engineering design standards, NFPA, applicable ASME standards, and building and permitting requirements
  • Experience coordinating design deliverables from early scope and Basis of Design development through construction documentation and execution support
  • Experience managing design reviews, compliance trackers, action and decision logs, risk logs, and cross-functional issue closure
Am I A Good Fit?
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The Company
HQ: Aguada, PR
76 Employees
Year Founded: 2008

What We Do

We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! Are We The Right Piece For You? We are: Experienced and knowledgeable in the Industry Committed to Safety Always compliant with FDA Regulations & Audits Cost Effective Proven successful track record Over ten (10) years of experience If you'd like to apply to any of our open positions, send us your updated resume in Word or PDF Format to [email protected]

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