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.
The Opportunity
As part of the Hillsboro IT OT team, you will report to the ITOT Infrastructure and Manufacturing Systems Lead and take the System Ownership and local Product Ownership accountabilities for the MES system and ensure robust support for Product Transfers and Make/Assess/Release in a 24x7 Goods Manufacturing Practice (GMP) environment. As part of the Site Team and broader Global IT OT organization, you will contribute to Manufacturing Operations Management initiatives and optimization/standardization of the global IT OT landscape.
Primary Responsibilities:
Serve as the System Owner / Local Product Owner for Manufacturing IT Applications in a 24x7 Good Manufacturing Practice (GMP) Pharmaceutical Manufacturing Facility
Oversee the entire system lifecycle of the MES system (Rockwell PharmaSuite), including procurement, design documentation, development, integration, modification, operation, maintenance, and retirement
Oversee computer systems qualification and validation
Address and mitigate global system application dependencies as global systems evolve their business processes and technologies (e.g., SAP upgrades, EDMS, LIMS integration)
Collaborate with site Business Process Owners to manage system upgrades, patches, and changes, ensuring GMP compliance
Identify opportunities to add value by improving business processes and enhancing patient outcomes through standardized technologies across sites
Define business criticality and product quality requirements in partnership with Delivery Service Managers, ensuring appropriate service levels, disaster recovery procedures, governance, change management, compliance, and operational support
Lead or coordinate technical discussions and vendor negotiations
Utilize the Agile delivery model, providing leadership, technical expertise, and local implementation experience as a member of Build and Run Squads
Support inspection readiness for internal and external regulatory audits
Who You Are
Bachelor’s Degree in Informatics, Engineering, or equivalent
Minimum of 5+ years of experience implementing and managing Manufacturing Systems solutions, preferably Rockwell PharmaSuite, or demonstrated experience that will facilitate rapid learning on the relevant platforms
Experienced in the Biopharmaceutical or similar Manufacturing domains
Proficient in informational and operational technologies (IT/OT), with expertise in MES integration and interfaces to enterprise global systems
Knowledgeable about Manufacturing Execution Systems (Preferably PharmaSuite), LIMS, PI Data Historian, Quality Management Systems (Preferably Veeva and ValGenesis), ERP, etc
Stays updated with key trends in Manufacturing IT, and maintains curiosity about Industrial IoT, Manufacturing Digital Plant Maturity, Cybersecurity, Pharma 4.0, Data Integrity principles, Technology, and data standardization
Exhibits the behaviors of a Lean-Agile Leader, with a Lean-Agile mindset
Knowledgeable of Good Manufacturing Practices (GMP), Health Authority practices, 21CFR Part 11, cGMP Annex 11, and Data Integrity principles
Experience with batch management and distributed control system
Experience with Microsoft SQL Server, SQL Scripting, and SQL Troubleshooting
24x7 support, participate in an on-call environment to meet business continuity requirements, including weekends and holidays if required
This position is based in Hillsboro, OR and has an in on-site requirement of 5 days/wk.
The expected salary range for this position based on the primary location of Oregon is $114,400 - $212,400. 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.
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What We Do
Considered the founder of the industry, Genentech, now a member of the Roche Group, has been delivering on the promise of biotechnology for more than 40 years.
Genentech is a biotechnology company dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.
We're passionate about finding solutions for people facing the world's most difficult-to-treat conditions. That is why we use cutting-edge science to create and deliver innovative medicines around the globe. To us, science is personal.
Making a difference in the lives of millions starts when you make a change in yours.
