Engineer - Drug Substance Manufacturing Support

BioPharma Consulting JAD Group; Juncos (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

BioPharma Consulting JAD Group seeks an Engineer to provide technical support for daily Drug Substance manufacturing at a biopharmaceutical site in Juncos, Puerto Rico. The role includes troubleshooting, process optimization, and upgrades to processes and equipment, ensuring all work complies with company policies, industry standards, and regulatory requirements.

Master's or Bachelor's with 2 years of engineering experience is required, with a background in mechanical, electrical, or chemical

Qualifications

• Master's degree or Bachelor's degree in Engineering plus 2 years of engineering experience.
• Background in Mechanical, Electrical and/or Chemical Engineering.
• Experience in regulated environments and GMP favored.

Responsibilities

• Provide technical problems solutions of moderate scope using standard engineering methods.
• Act as technical expert for process, equipment and systems during troubleshooting.
• Monitor manufacturing processes and KPIs; propose resolutions and guidance.
• Collaborate with Manufacturing, Maintenance, Process Development, Utilities, Facilities, QA and Validation on modifications.
• Support deviations, equipment qualification, process validation, procedures, training and new product introductions.
• Present results for operational issues and engineering projects.
• Support non-standard shift operations including nights and weekends.

Skills

Problem solving

Engineering fundamentals

Communication

Shift coordination

Education

Master's degree

Bachelor's degree with 2 years experience

Job description

We are seeking an Engineer to provide technical engineering support to continuous daily Drug Substance commercial manufacturing operations at a biopharmaceutical site in Juncos, Puerto Rico. This role performs troubleshooting, process optimization, and upgrades, replacements and modifications to processes and equipment, ensuring all work is performed in compliance with company policies, industry standards and regulatory requirements. This position supports non-standard shift operations.

Key Responsibilities

• Provide solutions to technical problems of moderate scope and complexity, applying standard engineering techniques and principles.
• Act as technical expert for process, equipment and systems during troubleshooting and multi-functional discussions.
• Monitor manufacturing processes and performance indicators; recommend problem resolution and provide troubleshooting guidance.
• Work with Manufacturing, Maintenance, Process Development, Utilities, Facilities, QA and Validation to define requirements and recommendations for process and system modifications.
• Support deviations, equipment qualification, process validation, procedures, training and new product introductions.
• Organize, analyze and present results for operational issues and engineering projects.
• Support 24/7 non-standard shift operations, including extended hours, nights and weekends as business needs require.

Education

• Master's degree; OR Bachelor's degree in Engineering + 2 years of engineering experience
• Background in Mechanical, Electrical and/or Chemical Engineering

Preferred Qualifications

• Experience with equipment and/or process troubleshooting in a regulated environment
• Knowledge of pharmaceutical/biotech processes and GMP production operations
• Familiarity with validation processes and validation protocol execution
• Ability to interpret and apply GMPs and GLPs

Key Skills

• Analytical problem solving and applied engineering
• Organizational and technical writing skills
• Presentation and communication skills in English and Spanish
• Ability to manage change and work in a fast-paced operations environment

• Contract position: approximately 5 months (October 2026 – March 2027), with possible extension
• Shift: Non-standard shift – 12-hour shifts on a 2-3-2 rotation, including nights and weekends
• On-site in Juncos, Puerto Rico