Under general supervision, the Manufacturing/Process Engineer provides technical support for process optimization, troubleshooting, and operational improvements in manufacturing, pilot plant, or capital projects. Applies basic engineering principles to implement system modifications, experiments, and capital projects, while organizing, analyzing, and presenting results for operational issues of minor to moderate complexity.

Key Responsibilities:

• Provide solutions to technical problems of moderate scope and complexity.
• Serve as a technical expert for equipment and systems, supporting troubleshooting and process optimization.
• Audit operational performance and regulatory compliance of equipment and systems.
• Collaborate with cross-functional teams (manufacturing, maintenance, process development, utilities, facilities, QA, and validation) to develop system modifications.
• Assist project managers with design, engineering, and construction projects within schedule and budget.
• Work with consultants and engineering firms to develop standard design documents.
• Obtain and review quotes for equipment modifications or installations.
• Generate project cost estimates and timelines.
• Support execution of manufacturing/quality systems, including deviations, equipment qualification, process validation, procedures, training, and new product introductions (NPI).
• Apply process, operational, and compliance expertise, including GMP and GLP standards.
• Organize, analyze, and interpret results from operational or engineering projects.
• Support 24/7 non-standard shift operations, including extended hours and weekends as needed.
• Perform additional duties as assigned to support manufacturing operations and continuous improvement initiatives.

Skills & Competencies:

• Problem solving and applied engineering
• Analytical thinking and interpretation of data
• Basic project management and validation protocol knowledge
• Computer literacy and proficiency with engineering tools

Requirements

Education & Experience:

• Master's degree in Engineering OR
• Bachelor's degree in Engineering + 2 years of relevant engineering experience

Preferred Qualifications:

• Educational background in Mechanical, Electrical, or Chemical Engineering
• Experience troubleshooting equipment or processes in regulated environments
• Knowledge of pharmaceutical/biotech manufacturing processes and GMP operations
• Strong technical writing, organizational, and presentation skills
• Bilingual in English and Spanish

Benefits

• Non standar shift
• Contract position