Process Validation Engineer II - 052

For Supply services in the Quality area.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Engineering and Science and five (5) years of exposure within the Medical Devices Industry.
• Bilingual: Spanish and English
• Soft Skills: Excellent Communication skills
• Shift: Administrative and according to business needs. 
• Experience in: 
  • Utilities Equipment.
  • Validation, Qualification phases, and commissioning.
  • Validation of facilities and utilities equipment, including air compressor and HVAC system
  •  Operational SOP, validation protocols, and maintenance plan.
  • Agile and SAP Systems.
  • Air Compressors and Mechanical Equipment's.

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)

• Provides technical and sustaining engineering support in a manufacturing area.
• Responsible for developing, executing, and managing validation activities for utility systems in compliance with regulatory requirements and internal quality standards.
• This role focuses on ensuring the qualification, performance, and reliability of critical utility systems, including but not limited to water systems, compressed air, and HVAC.
• The ideal candidate will have experience in utilities validation and a thorough understanding of GMP regulations.
• Conduct utilities qualification activities such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques, as well as production yields for existing products.
• Integrates equipment and material capabilities to meet process module target specifications and technology target specifications.
• Reviews product development requirements for compatibility with processing methods to determine costs and schedules.
• Interacts with product design and development personnel to ensure that processes and designs are compatible.
• May develop and conduct statistical analysis or recommend additions to document work. Leads the innovation, development, and/or optimization of new manufacturing concepts, processes, and procedures for transfer to manufacturing operations.
• This can include scouting and feasibility work, material selection, process and equipment selection, tooling fixture and equipment installation, and assessment of inputs, outputs, and alignment to requirements.
• Develops manufacturing processes that are applicable to statistical process control and may develop those techniques, including the measurement systems.
• Ensures processes and procedures are in compliance with regulations.

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 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?