The Role
Lead process optimization, troubleshooting, and major system modifications for manufacturing/pilot plant operations. Design and implement experiments and capital projects, analyze results, improve equipment reliability, and coordinate cross-functional teams including mechanics, automation, IS, quality, and validation.
Summary Generated by Built In
We are seeking a Sr. Engineer who will provided and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.
- Maintenance knowledge and experience with automated and manual inspection equipment operation.
- Technical knowledge of inspection technologies for parenteral and glass containers
- Apply sophisticated and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or projects.
- Apply standard engineering techniques and procedures to improve equipment reliability and performance
- Interact and provide direction to technical resources such as Mechanics, Automation Techs and IS teams.
- Work with other business functions such as research, manufacturing, process development, utilities, facilities, quality assurance and validation departments to support complex systems and/or facilities modifications.
Requirements
- Bachelor’s in engineering & over 4 years of Engineering experience in Mechanical, Electrical, or Industrial area.
- Technical writing and verbal communication in English and Spanish.
- Good organization, presentation and change management skills.
- Basic knowledge with validation and documentation processes in a highly regulated environment. Protocol Development and execution requirements.
Skills Required
- Bachelor's degree in Engineering
- Over 4 years engineering experience in Mechanical, Electrical, or Industrial disciplines
- Maintenance experience with automated and manual inspection equipment operation
- Technical knowledge of inspection technologies for parenteral and glass containers
- Technical writing and verbal communication in English and Spanish
- Basic knowledge of validation and documentation processes in a regulated environment; protocol development and execution
- Ability to direct technical resources (mechanics, automation technicians, IS teams)
- Organization, presentation and change management skills
- Ability to collaborate with research, manufacturing, process development, utilities, facilities, QA and validation
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The Company
What We Do
QRC Group specializes in providing expert consulting services in regulatory compliance, quality management, and risk management for the pharmaceuticals, medical devices, biotechnology, and other regulated industries, delivering comprehensive project management and validation solutions.
