MES Engineer

F. Hoffmann-La Roche AG; Hillsboro (OR); On-site; USD 79,000 - 177,000; Full time

Job summary

Genentech Hillsboro, a Roche subsidiary, seeks an IT/OT professional to design, validate and troubleshoot MES recipes (Rockwell PharmaSuite) in a highly automated GMP setting. You will support Make/Assess/Release operations and collaborate with the Hillsboro IT OT team to optimize manufacturing data and plant performance.

Reporting to the Manufacturing Systems Development Lead, you will author MES recipes, ensure compliance with quality processes, manage change records in Veeva, and coordinate

Qualifications

• BS/MS in Chemical, Electrical, Mechanical Engineering, Computer Science or equivalent.
• 2-4 years of relevant experience.
• MES Recipe Authoring experience preferred.

Responsibilities

• Author MES Rockwell (PharmaSuite) recipes and software development.
• Troubleshoot MES execution and system integration issues on the plant floor.
• Ensure compliance with corporate and site processes, design principles, and quality procedures.
• Develop qualification test plans and review/approve executions.
• Document system changes and incidents in ServiceNow.
• Own and manage Change records and Deviations in Veeva Quality System.

Skills

MES Recipe Authoring

Project management

Multi-tasking

Testing & validation

Autonomous work

Education

BS/MS in Chemical, Electrical, Mechanical Engineering, Computer Science or equivalent

Tools

ServiceNow

Veeva Quality System

Rockwell PharmaSuite MES

Job description

Are you passionate about Information (IT) and Automation Technology (OT) and aspiring to make a meaningful impact? Are you curious to shape a digital manufacturing architecture, ready to advance competitiveness on the market? This role could be for you!

We Make Medicines! Behind every product sold by Roche is Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes lifesaving medicines at 11 locations, with the support of partners from around the world. Information (IT) and Automation Technology (OT) teams are key in producing and delivering medicine to patients. The organization is currently undergoing a transformation towards digitalization, advancing fundamental elements to meet future needs, such as using new technologies.

The Opportunity

This position, based in Genentech's Hillsboro, Oregon facility, provides the opportunity to have a key role in a highly automated pharmaceutical drug substance facility. The site employs highly integrated computer control systems to manage plant operations and manufacturing data. The IT OT Team in Hillsboro is supporting Hillsboro Technical Operations (HTO) which is the commercial Make Assess and Release (MAR) and launch site for North America, and Hillsboro Innovative Therapies (HIT) which is transitioning into a multi-product facility for development, clinical and commercial supply capabilities for individualized and cell therapies.

As part of the Hillsboro IT OT team, you will report to the Manufacturing Systems Development Lead to support the Manufacturing Execution System (MES) as a Recipe Author, designing, building, validating, and troubleshooting MES recipes in support Make/Assess/Release in a 24x7 Goods Manufacturing Practice (GMP) environment.

As part of the Site Team and larger Global IT OT organization, you will also be expected to contribute to Manufacturing Operations Management initiatives and optimization/standardization of the global IT OT landscape.

Responsibilities

• Manufacturing Execution System (MES) Rockwell (PharmaSuite) recipe authoring and software development
• Troubleshooting plant floor MES execution and business system integration issues
• Compliance with corporate and site business processes, valid design principles, and quality procedures
• Qualification test plan development/review/approval and execution
• Implementing production tech transfer requirements into automation IT systems
• Contribute to the development of solutions for reporting, production and operational analysis tools, recipe procedural enhancements, batch review/release, equipment automation integration, and business system integration
• Present system and electronic batch record process to health authorities
• Contributing to development of supply chain network MES standards and best practices
• Provide Consulting with Business Process owners in the Value Streams
• Contribute with MES Recipe Authoring knowledge to Projects/Squads for MES Projects, process improvement initiatives or support
• Participate in an after hours on-call support rotation
• Document system changes and incidents in ServiceNow
• Own and manage Change records and Deviation in Veeva Quality System

Who You Are

• A BS/MS in Chemical, Electrical, Mechanical Engineering, Computer Science or equivalent
• A minimum of 2-4 years of relevant experience
• MES Recipe Authoring experience preferred
• Project management skills
• Ability to multi-task while handling routine and impromptu assignments with minimal supervision
• Must be able to plan and perform testing, including documenting test conditions, expected results, and test validation
• Must be comfortable working under pressure, delivering quality results with schedule deadlines and have a proven track record in meeting schedule for tasks while still meeting or exceeding business requirements and goals
• Work autonomously direct with Engineering and Value Streams
• Work with Global Recipe Authors Team on common templates for Rockwell PharmaSuite MES
• Job duties include after hours on call support at least one week a month

The expected salary range for this position based on the primary location of Oregon is $78,900 - $176,800. 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

Relocation benefits are not available for this job posting.

Genentech 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 company's 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.

Who We Are Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. The next step is yours.

Genentech 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 company's 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.