The Engineer II will be responsible for solving a wide range of difficult validation activities and issues that impact commercial manufacturing following cGMP regulations and Genentech standards. Perform assigned tasks and work to achieve company goals and department objectives.

Job Duties/Responsibilities:

o Follow company policies and procedures.
o Maintain a state of inspection readiness.
o Manage equipment, utility, process and facility validation and revalidation projects.
o Develop validation and revalidation project plans.
o Act as project manager for validation teams ensuring new systems are implemented within predetermined timelines and financial forecasts.
o Validate equipment, utilities, processes and facilities.
o Prepare validation protocols.
o Coordinate the collection, testing and analysis of samples and reporting of results required per validation protocol.
o Collaborate with departments to ensure validation activities are executed efficiently and effectively.
o Prepare validation summary reports for validation activities.
o Review and approve validation documentation.
o Provide technical assessment and approval for engineering and process changes.
o Provide input into investigations with potential validation impact.
o Present and provide rationale for the validation program during periodic audits and regulatory inspections.
o Prepare, review and approve relevant sections of regulatory submissions.
o Procure and manage contractor support for outsourced validation assignments.
o Support the change management system for validated equipment, utilities and facilities.
o Participate in external vendor audits.
o Provide input into the design and presentation of department performance metrics.
o Provide input to the development of personal performance goals and departmental objectives.
o Collaborate with Management to establish and meet targets and timelines.
o Support routine operations and allocate assigned resources.
o Manage competing priorities.
o Serve as the Quality representative on cross-functional and multi-site teams.
o Identify, design, and implement process and system improvements.
o Participate in the design and implementation of department and cross-functional initiatives.
o Apply advanced theory, technical principles, and expert judgment to address a broad range of difficult problems.
o Troubleshoot and support the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
o Serve as a technical subject matter expert (SME) in support of department functions.
o Train personnel and internal customers on relevant business processes.
o Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
o Be accountable for behaviors as described in Genentech's Core Competencies.
o Perform any other tasks as requested by Management to support Quality oversight activities.

Qualifications:
-B.A./B.S. degree (engineering or science degree preferred) and a minimum of 3-5 years of Validation experience in the pharmaceutical or biopharmaceutical industry
-Knowledge of cGMPs or equivalent regulations
-Ability to interpret and relate Quality standards for implementation and review
-Ability to make sound decisions about scheduling, allocation of resources, and managing priorities
-Ability to interpret and relate Quality standards for implementation and review
-Ability to communicate clearly and professionally both in writing and verbally
-Flexibility in problem solving, providing direction and work hours to meet business objectives
-Project Management experience is preferred but not required


DIVISION: Hillsboro
REQUISITION NUMBER: 09-1000030148