Vacaville, California
Who We Are
At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.The Position
Description:Reporting to the Group Leader of Automation Standards and Computer System Validation within the Vacaville Technology department, the Sr. Computer System Validation Engineer/Computer System Validation Engineer provides technical leadership and accountability for computer system validation engineering standards and computer systems validation for all site manufacturing related automation systems. In this position, the engineer is responsible for ensuring the successful delivery and maintenance of Pharmaceutical Quality System-compliant and reliable automation systems and the implementation of right first time projects and continuous improvement changes.
The Sr. Computer System Validation Engineer/Computer System Validation Engineer provides representation and input for the establishment and continuous improvement of site standards for Automation Engineering and in the efficient and compliant initiation and delivery of automation related capital projects to the Vacaville site. This position is accountable for the qualification lifecycle project scope for GMP automation systems on medium to large capital projects starting with project initiation and continuing through the project phases of planning, design, procurement, construction, commissioning, and equipment/system qualification. The Sr. Computer System Validation Engineer/Computer System Validation Engineer ensures that site engineering capital projects are compliant with the Roche Pharmaceutical Quality System (PQS) as implemented at the Vacaville site in addition to ensuring that standards and practices are in place to operate and maintain the site automation systems in a state of PQS and regulatory compliance. This position requires periodic travel to various Roche and vendor sites. Off-shift and extended hours may also be required on an occasional basis.
Responsibilities:
- Responsibilities include computer system validation for all manufacturing related automation systems at the Vacaville site including distributed control systems, building automation system, programmable logic controllers, utilities control system, manufacturing execution systems, batch and continuous historians, and associated business system interfaces.
- Areas of expertise are GMP automation/computerized systems within biologics drug substance and utilities.
- Manages assigned project goals within scope, on budget, and on schedule.
- Determines computer system validation strategy for automation system qualification in alignment with the Roche PQS.
- Develops computer system validation related content for project qualification plans and protocols.
- Plans, schedules and executes automation system commissioning and qualification activities.
- Measures and reports project execution progress for computer system validation.
- Leads/participates in decision-making and makes recommendations regarding best options.
- Communicates proactively with stakeholders and management regarding progress, issues, and plans for resolution.
- Develops and uses resource plans to coordinate computer system validation project staff, including Genentech and/or contract engineering resources.
- Directs communications to ensure the project team and/or network is fully informed of updates and improvements.
- Works under limited direction.
- Establishes own work priorities and timelines in alignment with project and department needs.
- Responsible for increasing the efficiency and effectiveness of Vacaville Automation Engineering by contributing to the improvement of departmental infrastructure (e.g., guidelines, procedures, practices, standards) either individually or through leadership of a team (departmental or cross-functional).
- Provides technical leadership and mentoring for other team members and colleagues. This role includes sharing insights and improvements, as well as participating in strategy sessions, design reviews, and project reviews.
- This qualified individual works collaboratively and effectively on multi-discipline cross-functional teams with representatives from departments across the site and Roche network.
- Generates controlled documents to support the start-up, validation, operation and maintenance of site GMP automation systems.
- Supports health authority inspections and internal and partner audits, and implements corrective actions as needed.
Who You Are
Qualifications:- Collaborative Leadership – Looks for opportunities to help others. Works well in a collaborative team environment and communicates effectively with customers, peers, and management. Demonstrates respect and appreciation for a diversity of perspectives. Maintains professionalism in presence of conflict.
- Technical Leadership – Demonstrates ability to provide technical leadership and teamwork in a GMP environment across functional and organizational boundaries.
- Ownership and Accountability – Takes accountability for actions, drives results, and learns from mistakes. Holds oneself accountable to fulfill assigned tasks and achieve results within timelines. Initiates additional assignments and assumes responsibilities as appropriate. Determines methods and procedures on new assignments.
- Communication – Is thorough in capturing all relevant information in communications. Conveys concepts and positions clearly, with straightforward language, both verbally and in writing. Readily grasps the main points in communication from others. Asks questions for clarification.
- Planning/Organization – Responds to new requests with appropriate urgency and with an organized approach.
- Problem Solving – Identifies problems, defines problem statement clearly and accurately, and applies structured and disciplined methodology to identify root causes. Is effective in solution development, risk mitigation, stakeholder buy-in, and execution.
- Customer Focused – Partners with customers and looks ahead to predict future customer needs. Manages expectations.
- BS in Engineering or Computer Science with a minimum of 5-8 years of computer system validation experience or an equivalent combination of education and experience.
- 5 years or more in the pharmaceutical or biopharmaceutical industry with GMP experience.
- Expertise as a practicing professional in the area of computer system validation.
- Thorough understanding of industry standards and best practices for computer system validation such as GAMP 5 and ASTM E2500.
- Knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9 and Q10.
- Practical experience with quality risk management and risk based validation approaches.
- Ability to perform work under limited direction and guidance.
- Demonstrated ability to effectively communicate, influence and lead both with and without authority, as well as strong interpersonal, leadership and collaboration skills.
- Demonstrated ability to work on multiple projects.
- Demonstrates excellent organizational and time utilization skills.
Genentech is an Equal Opportunity Employer.
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