Senior Engineer 35449

Job Summary

Required Qualifications

• •Bachelor's Degree in Engineering or a related technical discipline
• •Minimum of 4 years of engineering experience in the pharmaceutical or medical device industry
• •Doctorate in Engineering
• •Master's Degree with 2 years of engineering experience
• •Bachelor's Degree in Engineering with 4 years of engineering experience
• •Bachelor's Degree in Mechanical, Electrical, Industrial Engineering, or a related Engineering discipline
• •Minimum of 4 years of engineering experience
• •Pharmaceutical and biotechnology manufacturing processes
• •Medical device manufacturing processes
• •Packaging equipment and systems
• •Validation lifecycle and protocol execution
• •Good Manufacturing Practices (GMP)
• •Good Laboratory Practices (GLP)
• •Engineering documentation within highly regulated environments
• •Equipment qualification and commissioning
• •Manufacturing process optimization
• •Specialized manufacturing equipment
• •Engineering software and computer applications
• •Advanced engineering problem-solving
• •Process optimization
• •Equipment design and implementation
• •Technical investigations
• •Root cause analysis
• •Engineering calculations
• •Scientific decision-making
• •Validation protocol development and execution
• •Equipment qualification
• •Documentation in regulated manufacturing environments
• •Understanding of GMP and GLP requirements
• •Project planning and scheduling
• •Budget development and monitoring
• •Project execution and follow-up
• •Ability to manage multiple projects simultaneously
• •Financial analysis fundamentals
• •Strong leadership and team-building skills
• •Effective collaboration across cross-functional teams
• •Negotiation and conflict resolution
• •Excellent verbal and written communication in English and Spanish
• •Strong organizational and facilitation skills
• •Ability to independently identify when additional internal or external resources are needed
• •Ability to solve technical problems ranging from moderate to highly complex
• •Strong analytical thinking and decision-making skills
• •Ability to manage contractors and vendors
• •Ability to influence teams and drive engineering initiatives
• •Advanced problem-solving abilities
• •Process optimization
• •Equipment-specific technical expertise
• •Validation protocol writing and execution
• •Technical report writing
• •Technical presentations
• •Analytical thinking
• •Scientific decision-making
• •Project planning and scheduling
• •Budget development
• •Project execution and follow-up
• •Ability to manage multiple projects simultaneously
• •Financial analysis fundamentals

Desired Qualifications

• •Pharmaceutical or Medical Device manufacturing environments
• •Packaging equipment and manufacturing systems
• •Design and implementation of new equipment and manufacturing processes
• •Engineering project execution and support
• •Equipment qualification and validation activities
• •Capital improvement projects
• •Process optimization and troubleshooting
• •Technical writing and engineering documentation
• •Maintenance of automated and manual inspection equipment
• •Operation and troubleshooting of inspection systems
• •Technical knowledge of inspection technologies for parenteral manufacturing and glass containers
• •Equipment reliability and performance improvement
• •Engineering support in highly regulated pharmaceutical or biotechnology environments
• •Collaboration with cross-functional teams including: Manufacturing, Process Development, Research, Utilities, Facilities, Quality Assurance, Validation
• •Strong technical writing skills
• •Strong organizational, presentation, and change management skills
• •Develop and implement process improvements to increase operational efficiency and equipment performance
• •Troubleshoot manufacturing and operational issues using sound engineering principles
• •Analyze engineering data and present technical recommendations to support business decisions
• •Develop engineering procedures and technical documentation that support multiple functional areas
• •Serve as a technical resource and subject matter expert within assigned engineering disciplines
• •Design and implement engineering solutions for equipment modifications and manufacturing improvements
• •Collaborate with Project Managers to ensure projects are completed on schedule, within budget, and in compliance with quality standards
• •Coordinate activities with engineering firms, consultants, architects, contractors, and vendors
• •Assist in the development and management of project budgets
• •Partner with multiple departments including: Manufacturing, Process Development, Research, Utilities, Facilities, Quality Assurance, Validation
• •Provide technical guidance to engineers, technicians, and engineering associates
• •Coordinate engineering activities across multiple projects
• •Review technical work and engineering deliverables
• •Delegate project tasks while ensuring successful execution
• •Manage contractor and vendor activities when required
• •Lead complex engineering assignments requiring innovative engineering solutions
• •Serve as a technical subject matter expert in at least one engineering discipline
• •Plan and execute engineering projects with minimal supervision
• •Improve equipment reliability, maintainability, and operational performance
• •Troubleshoot manufacturing and inspection equipment
• •Provide technical direction to: Mechanics, Automation Technicians, Information Systems (IS) Teams
• •Recommend and implement equipment improvements
• •Develop technical solutions for complex engineering challenges
• •Support large-scale facility modifications and system upgrades
• •Partner with Project Managers to ensure projects are completed: On schedule, Within budget, According to quality standards
• •Coordinate work with consultants, architects, contractors, and engineering firms
• •Develop project budgets and monitor engineering expenditures
• •Partner closely with: Manufacturing, Process Development, Research, Validation, Quality Assurance, Utilities, Facilities
• •Coordinate and review the work of engineers, technicians, and engineering associates
• •Provide technical guidance throughout project execution
• •Manage contractor and vendor activities when required
• •Delegate project responsibilities effectively while ensuring successful project completion