Project Engineer

For Project Validation services in the Engineering & Manufacturing areas.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Engineering or Science and at least four (4) years of exposure to Manufacturing activities within the Pharmaceutical or Medical Devices industry. 
• Ability to lead teams through complex projects and provide departmental technical leadership.
• Bilingual (Spanish and English)
• Shift: Administrative & according to business needs 
• Experience in:
  • Validations such as manufacturing equipment, manufacturing processes, stability, or aging are required.
  • Technical documentation such as Change Controls, Validation Plans, Validation Protocols, Technical/investigation reports, SOP, and others.
  • GMP & GDP regulations

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 leadership in the areas of medical device life cycle management, supplier change management, COGs, process development, validation, and production stability.
• Participate on cross-functional project teams including R&D, Quality Assurance, Supplier Quality, Planning, Purchasing, Regulatory, and manufacturing to maintain and improve surgical products.
• Responsible for reviewing and updating applicable product specifications and drawings for legacy products. Responsible for identifying acceptance criteria for product specifications.
• Develop project plans for qualifications and ensure team resources identified, team members help accountable to deliverables, and milestones met.
• Provide engineering knowledge and resolve design, manufacturing, and quality-related problems impacting existing products.
• Develop and issue change control documentation to address changes in components and/or raw materials requested by the suppliers following applicable procedures.
• Ability to adjust priorities when with shifting business needs.
• Support manufacturing process improvements for CSS products in both internal manufacturing facilities and in partnership with external suppliers.
• Provide project leadership to improve existing products and associated manufacturing processes.
• Support the selection and validation of replacement materials, such as polymers, metals, and adhesives, for CSS applications.
• Support corrective actions and the implementation of all corrective actions to ensure improvements are attained.

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?