Product & Process Engineer

Loxo; Guayama (PR); On-site; USD 90,000 - 140,000; Full time

Job summary

Loxo is seeking a Product & Process Engineer to identify opportunities and develop solutions that improve quality, yield, efficiency, profitability, customer service, and compliance. This role supports process improvements through new technologies and regulatory requirements in manufacturing processes.

You will define process specifications, evaluate changes, lead Technology Transfer initiatives, develop project plans, and collaborate with Manufacturing, QA/QC, Engineering, and Development

Qualifications

• Bachelor’s degree in Engineering or Natural Sciences.
• 8+ years of relevant professional experience.
• Immediate availability required.
• Puerto Rico resident; onsite in East/South PR.

Responsibilities

• Define process, material, and product specifications.
• Evaluate changes via simulations, testing, or other methods.
• Lead Technology Transfer initiatives between sites.
• Develop detailed project plans and prioritize activities.
• Collaborate with cross-functional teams to resolve issues and optimize output.
• Troubleshoot and resolve complex process problems.

Skills

Process engineering

Quality improvement

Regulatory compliance

Technology transfer

Project management

Education

Engineering or Natural Sciences

Job description

Availability: Immediate availability required

Position Summary

Our client is seeking a Product & Process Engineer to identify opportunities and develop solutions that improve quality, yield, efficiency, profitability, customer service, and compliance. This role supports process improvements through the application of new technologies and techniques, process upgrades, regulatory requirements, and changes needed to incorporate new components or materials into existing manufacturing processes.

Key Responsibilities

• Define process, material, and product specifications for both control and response variables.
• Evaluate proposed changes and alternatives through theoretical studies, simulations, laboratory testing, or other appropriate methods.
• Apply technical knowledge across multiple areas of process technology to support manufacturing and process improvement initiatives.
• Develop detailed project plans and prioritize activities to achieve project goals.
• Lead implementation efforts with full responsibility for smaller-scope projects or specific portions of larger projects.
• With supervisory guidance, maintain responsibility for applying technology across multiple projects or work cells.
• Identify, resolve, and remove systemic limitations and barriers that may affect task completion, escalating significant issues to management when necessary.
• Lead Technology Transfer initiatives when technologies, processes, or products are transferred between commercial manufacturing sites.
• Lead proactive problem-solving efforts related to manufacturing processes.
• Troubleshoot and resolve moderate to highly complex process issues by diagnosing technical problems and determining short- and long-term solutions.
• Develop and implement systematic methods to evaluate manufacturing process and equipment problems, analyze process data related to equipment failures, and recommend actions to prevent recurrence.
• Collaborate with cross-functional teams to resolve system issues, optimize output, minimize contamination, and control costs.
• Design modifications to existing process equipment and support the implementation of new processes.
• Work closely with Manufacturing, QA/QC, Engineering, and Technology groups on technical issues and project teams.
• Collaborate with Development teams during new product development by providing a commercial operations perspective on process design and development.
• Provide input on the application of technologies that support robust, productive, and practical commercial-scale processes while optimizing capital investment.
• Consider commercial-scale quality, compliance, and financial requirements when supporting raw material selection.
• Identify opportunities to incorporate Process Analytical Technologies (PAT) to enhance process monitoring and improve control.
• Prepare technical documents, order and assemble equipment, and procure raw materials as required.
• Provide technical support for clinical material production.
• Monitor production activities and summarize campaign outcomes, including release test results, in technical reports.
• Execute process and cleaning validation activities.
• Provide support for equipment and systems qualification and validation studies, as required.

Minimum Qualifications

• Bachelor’s degree in Engineering (such as Chemical or Industrial Engineering) or Natural Sciences (such as Microbiology, Biology, Pharmacy, or Chemistry).
• Degrees in other fields, such as Business, may be considered when supplemented by relevant technical work experience.
• Minimum of 8 years of relevant professional experience.
• Immediate availability is required.
• Must be a Puerto Rico resident.
• Must be available to work onsite in the East/South area of Puerto Rico.