Manufacturing Engineer I

ECHO Consulting Group; Puerto Rico; On-site; USD 70,000 - 90,000; Full time

Job summary

ECHO Consulting Group is seeking an experienced individual contributor to advance R&D, systems or initiatives related to new technologies or therapies, from design to implementation, while adhering to policies and using specialized skills.

The role focuses on delivering projects in CQV, quality management, regulatory compliance, and manufacturing support, with potential mentorship and leadership of lower-level professionals. 1st shift in Villalba, PR.

Qualifications

• Experience in software and computer equipment validation (CSV) in regulated environments.
• Strong written and verbal technical communications in English and Spanish.
• Ability to work independently with general supervision and collaborate with process owners to develop and execute protocols.

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 efficient and productive layout.
• Designs sequence of operations and specifies procedures for fabrication of tools/equipment affecting product performance.
• Adapts machine or equipment design to factory and production conditions.
• May incorporate inspection and test requirements into the production plan; inspects performance and initiates corrective action to ensure product quality.
• Develops manufacturing processes applicable to statistical process control and may develop those techniques.
• Provides guidance to engineering regarding design concepts and specification requirements to utilize equipment and manufacturing techniques.
• Ensures processes and procedures are in compliance with regulations.

Skills

Autonomy

Organizational Impact

Innovation and Complexity

Communication and Influence

Communication

Education

Bachelors degree in Engineering

Job description

ECHO Consulting Group is a leader in providing solutions for the pharmaceutical, biotechnology, medical devices, and food industries. ECHO Consulting Group delivers high-quality solutions in CQV, quality management, regulatory compliance, manufacturing support, and project management. We are committed to offering exciting career opportunities in a workplace that values trust, respect, teamwork, creative talent, enthusiasm, and diligence. We are looking for talented professionals who are passionate about quality, collaboration, and delivering results. We believe great talent deserves great rewards. That’s why we offer a competitive compensation package and professional development.

Summary of Role

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.

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.

Shift: 1st Shift

Location: Villalba, PR

Education: Bachelors degree in Engineering

Preferred Qualifications

• Experience in performing software and computer equipment validation. Highly desirable previous experience executing CSV validation of Equipment Controller in a Medtronic 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.

Skills

• 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.

Equal Employment Opportunity

ECHO Consulting Group, Inc. is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law.

We assure you that your opportunity for employment with ECHO Consulting Group, Inc. depends solely on your qualifications.