Pharma Process Engineer – GMP Troubleshooting

Inteldot; Juncos (PR); On-site; USD 85,000 - 120,000; Full time

Job summary

Inteldot in Puerto Rico seeks a manufacturing/engineering professional to characterize and optimize processes in a regulated environment. You will design, implement system modifications, and organize analysis of results for projects of moderate scope and complexity.

The role emphasizes collaboration with Engineering, Operations, Maintenance, Quality, and Validation teams, with responsibilities spanning deviations, qualifications, process validation, and documentation.

Qualifications

• Experience with equipment and/or process troubleshooting in a regulated environment.
• Knowledge of pharmaceutical/biotech processes and GMP production operations.
• Organizational & technical writing skills.
• Experience supporting equipment and system decommissioning projects in a regulated manufacturing environment.
• Strong knowledge of GDP (Good Documentation Practices).
• Experience with change control processes and risk assessments.
• Knowledge of commissioning and decommissioning activities.
• Understanding of asset lifecycle management.
• Ability to coordinate cross-functional teams and stakeholders.
• Experience managing technical documentation and records.
• Capability to execute impact assessments and support regulatory compliance.
• Strong organizational, planning, and project management skills.
• Ability to manage multiple priorities and meet project deadlines.
• Technical troubleshooting and problem-solving skills.
• Experience driving continuous improvement initiatives.
• Self-motivated, detail-oriented, and proactive approach to work.
• Ability to collaborate effectively with Engineering, Operations, Maintenance, Quality, and Validation teams.

Responsibilities

• Provide solutions to a variety of technical problems of moderate scope and complexity.
• Under general supervision will evaluate, select and apply standard engineering techniques, basic principles and procedures.
• Function as a technical expert to process, equipment and/or systems during troubleshooting operations and multi-functional discussions.
• Routinely supervise manufacturing processes for performance indicators and operations; suggest problem resolution and mentoring.
• Work with manufacturing, maintenance, process development, utilities, facilities, quality assurance and validation departments to develop requirements and recommendations for modifications.
• Support the execution of manufacturing/quality systems such as deviations, equipment qualification and process validation, procedures, training, and new product introductions.
• Apply process, operational, scientific expertise and analytical skills to support manufacturing operations.
• Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of moderate scope and complexity.
• Apply basic engineering principles to the design and implementation of system modifications, experiments and capital projects.
• Support 7/24 non-standard shift operation including extended hours and weekends as per business needs.

Skills

Troubleshooting

Process optimization

Cross-functional collaboration

Project management

Documentation

Regulatory compliance

Continuous improvement

Technical writing

Problem solving

Organization

Education

Master's degree in engineering

Bachelor's degree in engineering

Mechanical / Electrical / Chemical engineering background

Job description

Inteldot in Puerto Rico seeks a manufacturing/engineering professional to characterize and optimize processes in a regulated environment. You will design, implement system modifications, and organize analysis of results for projects of moderate scope and complexity.

The role emphasizes collaboration with Engineering, Operations, Maintenance, Quality, and Validation teams, with responsibilities spanning deviations, qualifications, process validation, and documentation.