Manufacturing Engineer I

Weil Group•Villalba, PR

About The Position

This request is for the FACTORYworks (FW) Pulse project. FACTORYworks is an MES that is used in multiple manufacturing sites. There are ancillary software components that work in conjunction with FW that are developed by manufacturing sites. These software components can have different categorization. The most widely used are Equipment Controller (EC) and External Functions (EF). Both of these components are validated using the Global IT MSCM Procedure. In our client these software components are also in scope of a local quality requirement called Computer Software Validation (CSV). All documentation from MSCM is leveraged into CSV. However, CSV has one extra step that is exactly the same as an Installation Qualification process that requires having an approved protocol with representative test cases and an approved report, prior to releasing to manufacturing any computer that uses an EC o EF. The main scope of this position is to perform CSV on computers that are reserved for FW Pulse and require the use of a revision of an EC or EF that is different from the one currently in use in production. Prepare CSV protocols, execute them, and prepare reports that demonstrate that the new computer will function exactly as intended. This means that the new version of the EC or EF, functions exactly the same as the current computers with the current version of FW, EC, and EF.

Requirements

Experience in performing software and computer equipment validation. Highly desirable previous experience executing CSV validation of Equipment Controller in a facility.
Strong written and verbal technical communications skills in English and Spanish. Familiar with validation requirements in regulated industry. Capable of developing software qualification protocols and reports.
Must be capable of working independently with general supervision. Must collaborate with engineering process owners in development and execution of protocols. Must negotiate with operations and engineering process owners maintenance windows to execute protocols.
Requires broad theoretical job knowledge typically obtained through advanced education.
Requires an Engineering Bachelor's degree
0-3 years of experience required.

Responsibilities

Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
Adapts machine or equipment design to factory and production conditions.
May incorporate inspection and test requirements into the production plan.
Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques.
Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
Ensures processes and procedures are in compliance with regulations.
Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
May act as a mentor to colleagues or may direct the work of other lower level professionals.
The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.