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Under general supervision, the Engineer provides technical support across operations, manufacturing, pilot plant, and capital project environments. This role applies engineering principles to troubleshoot operational issues, optimize processes, and design/implement system modifications, experiments, and capital projects. The Engineer organizes, analyzes, and interprets data to resolve operational challenges and support engineering projects of moderate scope and complexity.

FUNCTIONS / RESPONSIBILITIES

• Provide solutions to technical problems of moderate scope and complexity.
• Evaluate, select, and apply standard engineering techniques, principles, and procedures; seek guidance for unusual or complex problems.
• Perform assignments with clear objectives requiring investigation of a limited number of variables.
• Initiate and complete routine technical tasks with minimal supervision.
• Organize, analyze, and present interpretation of results for operational issues or engineering projects.
• Serve as a technical expert for equipment, systems, and processes, providing troubleshooting support.
• Actively engage in daily operations when needed to meet schedules or resolve complex issues.
• Routinely audit operational performance and regulatory compliance of equipment and systems.
• Monitor manufacturing processes for performance indicators; recommend and implement corrective actions.
• Support execution of manufacturing/quality systems such as deviations, equipment qualification, process validation, procedures, training, and new product introductions.
• Participate in multi‑functional discussions as a technical subject matter expert.
• Work under the supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
• Collaborate with consultants, architects, and engineering firms to develop standard design documents.
• Obtain and evaluate quotes for equipment modifications or installations.
• Generate basic project cost estimates and schedules.
• Partner with manufacturing, maintenance, process development, utilities, facilities, quality assurance, and validation teams to develop requirements and recommendations for system or process modifications.
• Support troubleshooting, continuous improvement, and operational readiness activities.
• Support 24/7 non‑standard operations, including extended hours or weekends, as business needs require.

SKILLS

• Educational background in Mechanical, Electrical, Chemical, or related Engineering fields.
• Experience troubleshooting equipment and processes in a regulated environment.
• Working knowledge of pharmaceutical/biotech processes and GMP production operations.
• Familiarity with validation processes and documentation in highly regulated environments.
• Ability to interpret and apply GLPs, GMPs, and engineering science to production.
• Strong problem‑solving and applied engineering skills.
• Technical writing proficiency and ability to prepare basic technical reports.
• Strong verbal communication and presentation skills (English & Spanish).
• Understanding of validation protocol execution requirements.
• Skills in technical presentations, personal organization, validation protocol writing, change management, equipment‑specific technical knowledge, analytical problem‑solving, and computer literacy.

EDUCATION

• Master’s degree OR
• Bachelor’s degree in Engineering + 2 years of engineering experience.

PREFERRED QUALIFICATIONS

• Experience in biotechnology processes, particularly purification operations.
• Knowledge of chromatography and UFDF (Ultrafiltration/Diafiltration) techniques.
• Experience supervising manufacturing processes and providing troubleshooting mentorship.
• Ability to support deviations, CAPA, equipment qualification, and process validation activities.
• Experience designing and implementing system modifications, experiments, and capital projects.
• Strong organizational and technical writing skills.
• Proficient communication and presentation skills in English and Spanish.

• 6-month contract with possible extension
• Administrative and Non-Standard Shift