Job Description

For Project Management Services.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor’s Degree in Engineering or Science.
• Five - Seven (5–7) years of experience in manufacturing engineering or quality engineering within an FDA-regulated industry
• Bilingual: Spanish and English
• Soft Skills: Attention to detail, organization, and writing skills
• Shift: Administrative and according to business
• Experience:
  • Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), Good Manufacturing Practices (GMP), and ISO 13485.
  • Experience supporting new product introductions (NPI/NPD), including process development, equipment qualification, and process validation.
  • Hands-on experience with risk management (FMEA, hazard analysis), root cause investigations, and CAPA systems.
  • Proven collaboration with Operations, Quality Assurance, Regulatory, R&D, and Supply Chain teams.
  • Familiarity with controlled documentation systems, engineering change processes, and manufacturing readiness requirements.
  • Experience ensuring compliance with quality system procedures and regulatory expectations across the project lifecycle.

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)

• Project Planning & Definition: Define project goals, scope, resource and cost estimates, timeline, and risks. Facilitate cross-functional discussions to develop project proposals.
• People Leadership: Manage large, multi-project, multi-site cross-functional teams; provide performance input; foster strong alignment.
• Value Improvement (VIP): Oversee VIP initiatives; identify, communicate, and manage risks.
• Project / Program Management: Lead initiation, planning, execution, control, and closeout activities; ensure team ownership of plans, schedules, and budgets.
• Process Management: Ensure activities follow established processes; maintain
  documentation discipline; reinforce VIP and NPE best practices.
• Communications & Reviews: Drive cross-functional communication; serve as liaison between teams and leadership; lead phase reviews; maintain documentation including minutes, issue logs, and metrics.
• New Product Excellence (NPE): Implement NPE methods; manage NPE risks and deliverables.

WHO WE ARE:

We are a Service Provider company different from the rest. We pride ourselves on 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 the well-being of our resources, while providing our Pharmaceutical, medical device, and Manufacturing industry clients with top-notch quality talent. We're FITS!

Are you the next piece?