Process Engineer

Reposted 22 Days Ago
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Barceloneta, PRI
In-Office
Senior level
Pharmaceutical
The Role
The Process Engineer will manage equipment for syringe and cartridge filling processes, ensuring compliance and integration within facility design while coordinating cross-functional teams and supporting project execution.
Summary Generated by Built In

Process Engineering  Services.

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor’s Degree in Engineering (Mechanical, Chemical, Industrial or related field) and at least five (5) years of experience within the pharmaceutical or medical devices industry.
  • Bilingual: English and Spanish.
  • Soft Skills: Great attitude and strong desire to learn new skills.
  • Shift: Administrative, and according to business needs
  • Experience in: 
    • Syringes and cartridges filling and compounding processes and related equipment.
    • Process equipment package ownership, including procurement, design, and lifecycle management.
    • Coordination of process equipment within overall facility and project design.
    • Installation oversight and equipment startup activities.
    • Turnover of systems, documentation, and deliverables to CQV teams.
    • GMP environments and regulatory compliance.
    • Supporting capital projects and new facility expansions.

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 of 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 Be The Piece?

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

  • Act as the package owner for process equipment related to filling and compounding systems (syringes and cartridges).
  • Oversee procurement activities, including vendor coordination, technical evaluations, and equipment selection.
  • Ensure proper integration and alignment of equipment within the overall project and facility design.
  • Lead and support equipment design reviews, FAT/SAT, and installation activities.
  • Coordinate cross-functional efforts with engineering, operations, and CQV teams.
  • Ensure all documentation is complete and compliant for successful system turnover to CQV.
  • Support commissioning and qualification activities, ensuring readiness and compliance.
  • Drive project execution to meet timelines, budget, and quality standards.

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
  • At least five years of experience in the pharmaceutical or medical devices industry
  • Bilingual in English and Spanish
  • Experience in process equipment package ownership and lifecycle management
  • Experience in GMP environments and regulatory compliance
Am I A Good Fit?
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The Company
HQ: Guaynabo, 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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