Engineer - Drug Substance Manufacturing Support
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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.
Requirements
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
Benefits
Contract position: approximately 5 months (October ** – March **), 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
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