Manufacturing Engineer I

hace 4 semanas

Juncos, Puerto Rico Weil Group, Inc A tiempo completo
Brief description

Plan, write, implement, and review the Computer Systems Validation documentation. Make sure that all computer-based systems are operating as intended (with documents to prove it) and meet regulatory requirements. Determines systems software requirements. Work across a variety of software lifecycle activities as determined by project needs. Generate and execute qualification protocols and reports. Organize and maintain project status progress detail. Work with process owners to address process changes to existing work instructions and/or standard operating procedures.

What are the top 3 things you are looking for in a candidates experience:

Process and Computerized Systems Validation
Experience in FDA regulated industries
Excellent verbal and written communication skills (English and Spanish).
Education Required: Bachelor's degree in Engineering or related field.

Years’ Experience Required: 1-3 years

JOB DESCRIPTIONResponsibilities may include the following and other duties may be assigned.
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.

TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies.  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.

DIFFERENTIATING FACTORS
Autonomy: Entry-level individual contributor on a project or work team.
Works with close supervision.
Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities.
Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex.
Makes minor changes in systems and processes to solve problems.
Communication and Influence: Communicates primarily with internal contacts within immediate group.
Contacts others to gather, confirm and convey information.
Leadership and Talent Management: N / A – job at this level is focused on self-development.
Required Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced education. Requires a Bachelor's Degree in Engineering ,  1-3 years of experience required.

*Weil Group is proud to be an Equal Employment Opportunity Employer.*

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