Provide automation systems, control engineering, industrial network design expertise for existing facility projects, including upgrades and capacity expansions, equipment upgrading and replacement.
Lead the design, development and qualification of process automation systems, data infrastructure, business intelligence and data visualization systems.
Collaborate with IT on design, build and testing Automation system infrastructure, Virtualization, databases, network, firewall etc.
Ensures effective maintenance and availability of automation systems and equipment. Support software and hardware life cycle management efforts to maintain systems
Participate in all activities required to support production including but not limited to; campaign support, troubleshooting, rotational 24/7 on-call support, investigations, periodic reviews, root cause analysis, safety and quality preventative and corrective actions.
Monitoring and analysis of manufacturing data as necessary to provide support for process discrepancies, validation protocols, process transfers, or equipment troubleshooting.
Generate, review, and approve GMP Life cycle Documents (e.g. URS, FS, DS, drawings risk documents, trace matrices, periodic review, etc.)
Generate, execute, and review Installation, Operational, Performance Qualification
Manage 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.
Support inspection activities to present automation design and qualification deliverable and strategy (e.g. Qualification Project Plans and Master Plans).
Adhere to company policies regarding performance management, department time reporting and notification requirements, budget, and expense reporting guidelines.
Fosters a positive safety culture in which no one gets hurt.
Education and Experience
B.S. in Chemical, Electrical, Computer, Pharmaceutical Engineering or equivalent with experience in the life sciences industry.
Minimum 5 years automation focused industry experience involving automation design, automation performance analysis, or automation engineering services.
Minimum of 3 years in the pharmaceutical/biotech industry/GMP experience.
Extensive knowledge / experience with hardware and software development, database structure and queries, implementation and support for Emerson DeltaV and Syncade including integration of ISA-88 and ISA-95 Batch Standards.
A desire to innovate and improve processes by driving lean concepts in design and execution
Extensive knowledge of web method/web part development in .Net framework.
Experience in XML/B2MML and creation of style sheets.
Ability to work independently and collaboratively
Experience with industrial networks and communication protocols preferred
Experience with Manufacturing Execution System, Data Historians, ERP and IT data integration preferred
Knowledge, Skills and Abilities
Experience with Biopharmaceutical manufacturing, design or/and construction
Practical knowledge of distributed control system (DeltaV) and Manufacturing Execution System (Syncade), Database administration, Data Historians (OSI PI), networking and System Administration
Knowledge of GMP guidelines, experience in generation of controlled documents
Qualification experience related to control and computer systems
Knowledge of Crystal Report development
Proficient in use of SQL Management Studio, to include writing queries and stored procedures.
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 development
Ability to work independently with no direct supervision.
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.