Under general supervision, the Engineer supports process optimization, troubleshooting, and operational efficiency within manufacturing, pilot plant, or capital projects environments. This role applies fundamental engineering principles to design, implement, and improve systems, while analyzing and presenting data to resolve technical issues of moderate scope and complexity.
Key Responsibilities
- Provide solutions to technical problems of moderate scope and complexity
- Evaluate, select, and apply standard engineering techniques and procedures
- Execute assignments with clear objectives, involving limited variables and defined scope
- Initiate and complete routine technical and engineering tasks
- Analyze data and present findings and recommendations
- Serve as a technical resource for troubleshooting equipment and system issues
- Support day-to-day manufacturing operations to meet production schedules
- Audit operational performance and regulatory compliance of equipment and systems
- Collaborate with cross-functional teams (Manufacturing, Quality, Validation, Maintenance, Process Development, Utilities, Facilities) to define and implement system improvements
- Support design, engineering, and construction projects under project manager guidance
- Collaborate with external vendors, consultants, and engineering firms on design documentation
- Obtain, review, and evaluate equipment and modification proposals/quotes
- Develop basic project cost estimates and timelines
- Assist in execution of capital projects within scope, schedule, and budget
Requirements
Education & Experience
- Master’s degree in Engineering OR
- Bachelor’s degree in Engineering + 2 years of relevant engineering experience
Required Skills & Competencies
- Strong understanding of engineering principles applied to manufacturing operations
- Ability to troubleshoot equipment and process-related issues
- Knowledge of GMP and GLP regulations
- Familiarity with validation processes and documentation in regulated environments
- Ability to analyze data and develop practical solutions
- Strong technical writing and reporting skills
- Effective verbal communication and collaboration skills
- Basic project management and organizational skills
- Ability to manage multiple tasks and priorities
- Proficiency with computer systems and engineering tools
- Ability to operate specialized laboratory or process equipment
Preferred Qualifications
- Experience or knowledge in:
- Fermentation processes
- Cell culture operations
- Harvest and downstream processes
- Experience supporting commercial manufacturing campaigns
- Experience with validation protocol execution and documentation
- Skills in:
- Technical presentations
- Validation protocol writing
- Analytical problem solving
- Change management
- Equipment-specific technical expertise
Benefits
Work Schedule
- Administrative Shift: Standard business hours
- Flexibility required based on project and operational needs
