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 
• AND Minimum of 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