CIS International LLC
Summary
The Manufacturing Engineer is responsible for designing, developing, validating, and sustaining manufacturing processes, equipment, and systems to ensure efficient, compliant, and high-quality production. This role functions as an established individual contributor, supporting moderately complex projects and cross-functional initiatives within a regulated manufacturing environment.
Key Responsibilities Responsibilities may include the following and other duties may be assigned:
Design, develop, and optimize manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling.
Design plant and equipment layouts to ensure efficient, safe, and productive manufacturing operations.
Define sequences of operations and specify procedures for fabrication of tools, fixtures, and equipment impacting product performance.
Adapt machine and equipment designs to meet factory and production conditions.
Incorporate inspection and testing requirements into production and validation plans.
Perform process and equipment performance evaluations to verify efficiency, capability, and compliance.
Lead and support investigations, root cause analysis, and implementation of corrective and preventive actions (CAPA) to ensure product quality.
Provide technical and sustaining engineering support to manufacturing operations.
Develop and support manufacturing processes applicable to Statistical Process Control (SPC).
Apply statistical techniques to analyze process performance and drive continuous improvement.
Ensure manufacturing processes and procedures comply with applicable regulatory and quality requirements.
Support and execute Process Validation, Equipment IQ, and Computer Software Validation activities.
Provide technical guidance to design and engineering teams to ensure optimal use of equipment and manufacturing techniques.
Participate in cross-functional meetings and project teams to meet operational and project objectives.
Support project scheduling and execution to ensure deadlines are met without operational impact.
May mentor or provide guidance to entry-level engineers or support personnel.
Requirements Education
Bachelor’s degree required in Engineering
Minimum 2 years of relevant manufacturing engineering experience in the regulated industry.
Technical Knowledge & Skills
Knowledge of Process Validation, Equipment IQ, and Computer Software Validation
Experience conducting investigations and root cause analysis in manufacturing environments
Knowledge of statistical techniques and Statistical Process Control (SPC)
Ability to evaluate machinery, equipment, and tools to verify performance and efficiency
Experience supporting technical and sustaining engineering activities
Work Methodology
100% On-Site in Villalba, PR
Full time job
Professional services or W2 Temp job classification
Administrative shift from Monday to Friday (8am-5pm)
6 months of 1st contract up to 2 years based on performance and budget
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Key Responsibilities Responsibilities may include the following and other duties may be assigned:
Design, develop, and optimize manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling.
Design plant and equipment layouts to ensure efficient, safe, and productive manufacturing operations.
Define sequences of operations and specify procedures for fabrication of tools, fixtures, and equipment impacting product performance.
Adapt machine and equipment designs to meet factory and production conditions.
Incorporate inspection and testing requirements into production and validation plans.
Perform process and equipment performance evaluations to verify efficiency, capability, and compliance.
Lead and support investigations, root cause analysis, and implementation of corrective and preventive actions (CAPA) to ensure product quality.
Provide technical and sustaining engineering support to manufacturing operations.
Develop and support manufacturing processes applicable to Statistical Process Control (SPC).
Apply statistical techniques to analyze process performance and drive continuous improvement.
Ensure manufacturing processes and procedures comply with applicable regulatory and quality requirements.
Support and execute Process Validation, Equipment IQ, and Computer Software Validation activities.
Provide technical guidance to design and engineering teams to ensure optimal use of equipment and manufacturing techniques.
Participate in cross-functional meetings and project teams to meet operational and project objectives.
Support project scheduling and execution to ensure deadlines are met without operational impact.
May mentor or provide guidance to entry-level engineers or support personnel.
Requirements Education
Bachelor’s degree required in Engineering
Minimum 2 years of relevant manufacturing engineering experience in the regulated industry.
Technical Knowledge & Skills
Knowledge of Process Validation, Equipment IQ, and Computer Software Validation
Experience conducting investigations and root cause analysis in manufacturing environments
Knowledge of statistical techniques and Statistical Process Control (SPC)
Ability to evaluate machinery, equipment, and tools to verify performance and efficiency
Experience supporting technical and sustaining engineering activities
Work Methodology
100% On-Site in Villalba, PR
Full time job
Professional services or W2 Temp job classification
Administrative shift from Monday to Friday (8am-5pm)
6 months of 1st contract up to 2 years based on performance and budget
#J-18808-Ljbffr