Validation Engineer - 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?

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