Pubblicato il Pubblicato 20h fa
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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?
