Initiate, execute, and track progress of change records.
Manage personal project activities (design and qualification) following Genentech/Roche business processes to deliver results that are right first time, on-time with schedule requirements and reconciled to the budget.
Review and approve vendor information packages, including drawings and specifications as directed to ensure validation and control system requirements are met.
Lead the start-up and troubleshooting of automation and critical process utility systems.
Support plant operations to assess discrepant events and changes for automation impact, deliver automation solutions to resolve operational issues, assist in troubleshooting and providing real time on floor support of manufacturing operations, participate in site coordination meetings and attend network meetings.
Adhere to site SOPs and WIs for daily and project deliverables and drive improvements to business processes.
Support inspection activities to present automation design and qualification deliverables and strategy (e.g. Qualification Project Plans and Master Plans).
Attendance and participation in department and staff meetings.
Maintain training qualifications.
Adhere to company policies regarding performance management, department time reporting and notification requirements, budget, and expense reporting guidelines.
Automation lead for equipment/software FAT, field testing and commissioning.
Interact with vendors to ensure systems meet site requirements.
Provide scope, qualification, resource, and budget estimates for automation impacting projects.
Manage contractor staff, track project deliverables, and provide status updates to project team.
Generate, review, and maintain Master Plans and Project Plans with automation scope.
Select external contractors with appropriate skill sets.
Manage teams (contractor and FTE staff) by setting clear expectations for work delivered and behaviors. Monitor performance and ensure contractual obligations are met. Complete timely review of time sheets and invoices.
Provide input into network/global business processes and procedures (e.g. GSPs).
Support work of the Engineering Group, which includes research/evaluate instrumentation and control components, review/modify control system concept/logic as a result of troubleshooting.
Knowledge, Skills and Abilities
Experience with Biopharmaceutical manufacturing, design or/and construction.
Knowledge of process, utility and building control systems.
Knowledge of GMP guidelines, experience in generation of controlled documents.
Qualification experience related to control and computer systems.
Ability to generate engineering drawings and specifications.
Knowledge of ISA standards and practices for instrumentation.
Knowledge of PID control theories and techniques.
Knowledge of programmable logic controllers, and associated programming languages (RS Logix Preferred).
Practical knowledge of distributed control systems, and associated programming languages (DeltaV and Seimens Insight Apogee Preferred).
Knowledge of computer aided manufacturing automation.
Demonstrate good organizational and time utilization skills.
Demonstrate good interpersonal skills with an ability to interact well with a variety of personalities, discipline skills and educational levels.
Demonstrate good written and verbal communication skills.
Ability to comply with cGMP requirements (gowning, documentation, and procedures) for performing work within the manufacturing facility.
Demonstrate strong working knowledge of PC based programs and web based systems.
Ability to work independently with no direct supervision.
This position is not eligible for relocation.
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 40 years, using human genetic information to develop novel medicines for serious and
life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious
illnesses. Please take this opportunity to learn about Genentech where we believe that our employees
are our most important asset & are dedicated to remaining a great place to work.
The next step is yours. To apply today, click on the "Apply online" button.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.
At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.