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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:
Education
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.
Education
- Bachelor’s degree required in Engineering
- Minimum of 2 years of relevant manufacturing engineering experience in the regulated industry.
- 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
- 100% On-Site in Villalba, PR
- Full time job
- Professional services job classification
- Administrative shift from Monday to Friday (8am-5pm)
- 6 months of 1st contract up to 2 years based on performance and budget