Process Engineer

At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.

The Position

A healthier future. Its 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. Thats 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.

The Opportunity:

Process Engineer 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 Roches 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.

Quality and Safety Compliance

• 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 companys 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.

Continuous Improvement

• 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.

Who You Are:

Education and Experience

• Bachelors Degree (required) - preferred Engineering/Engineering Technology

• 3 years relevant work experience preferably in regulated industry

• Knowledge of lean principals and/or Six Sigma methodologies or Green Belt preferred

• Experience operating in a GMP/regulated environment preferred

Knowledge Skills and Abilities

• 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.

• Preferred experience in Google applications and Microsoft Office

• 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.

Relocation benefits are not available for this position.

• The expected salary range for this position based on the primary location of Tucson AZ is 60600.00 - 86500.00 - 112500.00 USD Annual. Actual pay will be determined based on experience qualifications geographic location and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an equal opportunity employer. It is our policy and practice to employ promote and otherwise treat any and all employees and applicants on the basis of merit qualifications and competence. The companys policy prohibits unlawful discrimination including but not limited to discrimination on the basis of Protected Veteran status individuals with disabilities status and consistent with all federal state or local laws.

If you have a disability and need an accommodation in relation to the online application process please contact us by completing this form Accommodations for Applicants.