Process Engineer

Roche•Tucson, AZ

About The Position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche. Roche is dedicated to evolving the practice of medicine and helping patients to live longer, better lives. Our operations are critical to the success of our company and our impact on society, doing now what patients need next. As a process engineer with a minimum of 1 years of experience in a manufacturing environment, your role will focus on continuous improvement, design, automation, cGMP compliance, and quality management of our manufacturing processes. You will evaluate existing processes and equipment to identify and implement opportunities for enhanced efficiency and effectiveness, leading Lean Manufacturing initiatives in partnership with the Process Engineering & Validations team. Your responsibilities will also include designing and implementing automation solutions to streamline manufacturing processes and supporting the Automation Technician team in resolving technical and compliance issues related to manufacturing equipment. You will ensure all processes and equipment adhere to current Good Manufacturing Practices (cGMP), monitoring factory floor operations to maintain quality and safety standards and participating in audits and inspections. Developing and implementing comprehensive preventive maintenance plans for manufacturing and test equipment will be crucial, as will coordinating with maintenance teams to ensure timely completion of scheduled maintenance, instrument service, and calibrations. You will also establish and maintain overall equipment effectiveness (OEE) improvement plans, create and track performance metrics, and identify areas for improvement. Furthermore, you will manage project timelines to ensure the timely completion of projects, including equipment repairs, maintenance, and upgrades, applying programmatic rigor to large projects. Roche encourages continuous learning and professional development, providing opportunities in a supportive and creative environment to help you grow in your career.

Requirements

Bachelor's Degree (required) - preferred Engineering/Engineering Technology
3 years relevant work experience, preferably in regulated industry
Strong analytical and problem-solving skills.
Proficiency in process simulation software and other engineering tools.
Basic knowledge of GMP (Good Manufacturing Practices) and regulatory standards.
Excellent communication and teamwork abilities.
Attention to detail and strong organizational skills.
This position may require the individual to wear and work in personal protective equipment.
Available for on-call duty for after-hours emergencies.
May work extended hours, weekends and/or holidays.

Nice To Haves

Knowledge of lean principals and /or Six Sigma methodologies or Green Belt, preferred
Experience operating in a GMP/regulated environment, preferred
Preferred experience in Google applications and Microsoft Office

Responsibilities

Design and develop manufacturing processes for new products or improve existing products, achieving a reduction in process cycle time.
Support process validation and qualification activities to ensure that validation protocols are completed on time.
Analyze process data and perform troubleshooting to resolve technical issues, achieving a decrease in downtime.
Collaborate with cross-functional teams, including R&D, Quality Assurance, and Production, to ensure seamless process integration, aiming for successful integration into production.
Participate in continuous improvement initiatives to enhance process performance and efficiency.
Utilize process simulation software and other engineering tools to optimize manufacturing processes.
Ensure compliance with regulatory requirements and Roche's internal quality standards, achieving audit readiness with zero non-conformances in routine audits.
Prepare and maintain accurate documentation, including process flow diagrams, work instructions, operating procedures and technical reports.
Conduct risk assessments and develop mitigation strategies for process-related risks, reducing identified risks.
Maintains Right to Operate by ensuring all processes are performed safely and healthily.
Identifies and escalates potential hazards, while promptly reporting and investigating safety incidents, hazards, and near misses using safety reporting tools.
Ensures all activities are conducted in strict adherence to current Good Manufacturing Practices (cGMP) as well as local, international and Roche (MQMS) standards.
Keeps updated with changes in relevant regulations and ensure the company’s practices remain compliant.
Assists in the audit readiness process by collecting and organizing required documentation, ensuring all necessary information is readily available, and supporting more experienced engineers in maintaining compliance and identifying potential issues.
Assists Non-Conformance Report (NCR) investigations, rework activities, and corrective actions as required.
Adhering to 95% or above internal training compliance.
Uses lean principles to identify and eliminate inefficiencies, redundancies, and non-value-added activities within assigned responsibilities.
Applies problem-solving methodologies, such as the Five Whys, Fishbone (Ishikawa) diagrams ensure proper root cause analysis
Uses statistical tools and software (e.g., Minitab) to analyze relevant data and generate actionable insights and ensure fact based decisions are made
Supports the development and maintains standardized procedures, documentation, and guidelines for processes.
Collaborates with other departments to identify and eliminate waste while ensuring quality remains uncompromised.