Genentech
The Position
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? We Make Medicines! Behind every product sold by Roche is Pharma Global Technical Operations (PT). Starting with PhaseI 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 a24x7 Goods Manufacturing Practice (GMP) environment. As part of the Site Team and larger Global ITOT organization, you will also be expected to contribute to Manufacturing Operations Managementinitiatives 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
Update and maintain Standard operating procedures associated with the MES systems and processes
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
Troubleshoot immediate system issues, and inquiries as they arrive during normal business hours.
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 4 years of manufacturing execution systems experience
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 $80,500 - $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 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 .
#J-18808-Ljbffr
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? We Make Medicines! Behind every product sold by Roche is Pharma Global Technical Operations (PT). Starting with PhaseI 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 a24x7 Goods Manufacturing Practice (GMP) environment. As part of the Site Team and larger Global ITOT organization, you will also be expected to contribute to Manufacturing Operations Managementinitiatives 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
Update and maintain Standard operating procedures associated with the MES systems and processes
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
Troubleshoot immediate system issues, and inquiries as they arrive during normal business hours.
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 4 years of manufacturing execution systems experience
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 $80,500 - $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 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 .
#J-18808-Ljbffr