Engineer - Process Optimization (Manufacturing & Capital Projects)

Job DescriptionJob Description

We are seeking a Process/Operations Engineer to support process optimization, equipment troubleshooting, and technical project execution within a regulated manufacturing or pilot plant environment. This role applies core engineering principles to system modifications, experimental design, and operational improvements. The engineer will analyze and interpret data to resolve issues and contribute to projects of moderate scope and complexity.

Key Responsibilities

• Provide solutions to a variety of technical problems of moderate scope and complexity.
• Evaluate, select, and apply standard engineering techniques, principles, and procedures under general supervision.
• Perform assignments with clear objectives and limited variables; assistance provided for unusual problems.
• Initiate and complete routine technical tasks related to operations and engineering.
• Function as a technical expert for equipment, systems, and processes during troubleshooting and cross-functional discussions.
• Actively engage in daily operations to meet production schedules and resolve complex issues.
• Routinely monitor manufacturing processes for performance indicators and operational efficiency.
• Recommend solutions and provide troubleshooting guidance to operations teams.
• Collaborate with manufacturing, maintenance, process development, utilities, facilities, QA, and validation teams to define requirements and recommend system or process modifications.
• Support execution of manufacturing and quality systems including deviations, equipment qualification, process validation, SOPs, training, and new product introductions.
• Apply scientific, operational, and compliance knowledge to support manufacturing operations.
• Organize, analyze, and present results related to operational issues or engineering projects.
• Apply basic engineering principles to the design and implementation of system modifications, experiments, and capital projects.
• Support design, engineering, and construction projects under the supervision of project managers.
• Work with consultants, architects, and engineering firms to develop standard design documentation.
• Evaluate and critique vendor quotes for equipment modifications or installations.
• Generate basic project cost estimates and schedules.

Requirements

• Master’s degree in Engineering
  OR
• Bachelor’s degree in Engineering with a minimum of 2 years of relevant experience
• disciplines: Mechanical, Electrical, or Chemical Engineering

Qualifications

• Experience with equipment and/or process troubleshooting in a regulated environment
• Knowledge of pharmaceutical/biotech processes and GMP production operations
• Familiarity with validation protocols and documentation in regulated settings
• Ability to interpret and apply GLPs and GMPs
• Experience supporting manufacturing operations through deviations, qualifications, and validations
• Strong organizational and technical writing skills
• Proficient presentation and communication skills in English and Spanish
• Ability to operate specialized laboratory equipment and engineering software tools
• Computer literacy and adaptability to new technologies

Benefits

• 4-month contract with possible extension
• Non-Standard Shift
• 12 hours a day, 48 hours a week
• Willingness to support 24/7 non-standard shift operations, including extended hours and weekends, based on business needs