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Flexible & Integrated Technical Services

Integrated CQV, compliance, and engineering services.

Process Engineer 1

Full-TimePosted on 8/15/2026
No salary listed
Mid
Bachelor's
Humacao, Puerto Rico
In Person
Manufacturing & Process EngineeringManufacturing Engineering

About the job

Requirements
  • Bachelor's degree in Mechanical, Biomedical, Industrial, or Chemical Engineering.
  • Three years of exposure within the medical devices industry.
  • Bilingual proficiency in Spanish and English.
  • Experience in validations and problem solving.
  • Excellent teamwork skills and a team-oriented approach.
Responsibilities
  • Provide technical and sustaining engineering support in a manufacturing area.
  • Recommend and implement equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques, and production yields for existing products.
  • Integrate equipment and material capabilities to meet process module target specifications and technology target specifications.
  • Review product development requirements for compatibility with processing methods to determine costs and schedules.
  • Interact with product design and development personnel to ensure processes and designs are compatible.
  • Develop and conduct statistical analyses or recommend additions to document work.
  • Lead the innovation, development, and/or optimization of new manufacturing concepts, processes, and procedures for transfer to manufacturing operations.
  • Conduct scouting and feasibility work; select materials, processes, and equipment; and perform tooling or fixture and equipment installation and assessment of inputs, outputs, and alignment to requirements.
  • Develop manufacturing processes applicable to statistical process control and potentially develop those techniques, including measurement systems.
  • Ensure processes and procedures comply with regulations.

About the company

F

Flexible & Integrated Technical Services

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FITS, LLC provides integrated engineering, compliance, and technical services to pharmaceutical, biotech, medical device, and healthcare organizations in Puerto Rico. It covers commissioning, qualification and validation (CQV), utilities and facilities engineering, maintenance, EHS, automation, and technical staffing to help clients maintain FDA-compliant operations and improve performance of mission-critical systems. Acting as an extension of client operations, FITS delivers turnkey projects, regulatory readiness, quality assurance, and continuous improvement with a multidisciplinary team to support site expansions and ongoing operations. Its goal is to help life-sciences and healthcare facilities scale safely and efficiently while ensuring reliable, compliant operations.

Company Size

51-200

Company Stage

Growth Equity (Non-Venture Capital)

Total Funding

$8M

Headquarters

Aguada, Puerto Rico

Founded

2008

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Simplify Jobs

Simplify's Take

What believers are saying

  • FITS posted active 2026 openings in validation, C&Q, project management, and process development.
  • Its 2026 jobs span Juncos, Dorado, Yauco, and Juana Díaz, signaling broad demand.
  • Federal contractor registration with SAM.gov expands access to government-funded facilities work.

What critics are saying

  • FITS depends on contract hiring, exposing revenue to client shutdowns and procurement delays.
  • Heavy concentration in Puerto Rico life sciences ties FITS to local plant expansions and slowdowns.
  • A rival integrator winning Amgen or J&J accounts would immediately compress FITS utilization.

What makes Flexible & Integrated Technical Services unique

  • FITS embeds CQV, utilities, and technical staffing inside Puerto Rico regulated plants.
  • Clients include Amgen, Lilly, Bristol Myers Squibb, Abbott, Johnson & Johnson, and CooperVision.
  • Founded 2008, FITS combines engineering, maintenance, and validation under one local service platform.

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Benefits

Flexible Work Hours

Growth & Insights

Headcount

6 month growth

-10%

1 year growth

-10%

2 year growth

-10%
INACTIVE