About this role
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