ABOUT US

LabChemS Corp (LCC) is a leading provider of consulting services, laboratories, and support resources for the medical device and pharmaceutical industries in Puerto Rico. Compensation will be determined based on the educational qualifications and experience of the selected candidate.

JOB SUMMARY

The Validation Engineer plays a crucial role in ensuring that manufacturing processes and products meet the required standards of quality and efficiency. This position involves validating equipment, processes, and systems within a manufacturing facility, with a strong focus on continuous improvement and compliance with industry standards. The ideal candidate will possess a blend of technical skills and practical experience in various engineering disciplines, particularly in manufacturing environments.

REQUIREMENTS

• Bachelor’s Degree in Engineering (Mechanical is preferred).
• At least one year of hands-on experience in validation activities (IQ, OQ, PQ) and manufacturing processes
• Experience with process transfers is preferable.
• Proficiency in project scheduling and management techniques.
• Strong mechanical knowledge with experience in mechanical engineering principles.
• Experience working within a manufacturing facility environment, preferably pharmaceutical, medical device or biotechnology industries.
• Ability to read and interpret schematics effectively.
• Experience with industrial equipment maintenance and troubleshooting.
• Strong understanding of GMP, GDP, and applicable FDA/ISO regulatory standards.
• Familiarity with risk assessment tools (FMEA, HACCP).
• Experience with equipment calibration.
• Familiarity with continuous improvement methodologies such as Six Sigma or Kaizen is a plus.
• Proficient in Microsoft Office Suite and statistical analysis tools (e.g., Excel, Minitab).
• Strong analytical thinking and problem-solving abilities.
• Ability to manage multiple tasks and prioritize workload.
• Excellent technical writing and documentation skills.
• Clear and professional communication skills in Spanish and English (written and verbal).
  Job Types: Full-time, Contract
  Pay: $25.00 - $30.00 per hour
  Expected hours: No less than 40 per week
  Work Location: In perso

• Develop and execute validation protocols for manufacturing processes, equipment, and systems.
• Conduct root cause analysis to identify issues affecting product quality or process efficiency.
• Collaborate with cross-functional teams to ensure compliance with ISO 9001 standards.
• Utilize AutoCAD and SolidWorks for designing and modifying schematics related to validation projects.
• Program and troubleshoot programmable logic controllers (PLCs) as part of process validation.
• Implement lean manufacturing principles to enhance operational efficiency.
• Oversee the validation of plastics injection molding processes and equipment.
• Engage in continuous improvement initiatives to optimize production workflows.
• Conduct inspections using vision inspection systems to ensure product quality.
• Provide support in CNC programming, CAM programming, and GD&T applications as needed.
• Participate in factory operations, including assembly line processes, welding, fabrication, and tooling activities.