Validation Engineer - Biopharma

Job description

  Job facts

In this role in our South San Francisco manufacturing site, you will be responsible for a variety of validation activities and for resolving challenging issues following cGMP regulations and company standards. This position requires a problem solving mindset with strong technical and/or engineering knowledge, as well as strong ability to work collaboratively with interfaces to Process Engineering, Quality, Project Managers, Facilities, Automation and other groups.

General Job Responsibilities

·  Serve as the Validation Engineering representative and technical subject matter expert (SME) on cross-functional and multi-site teams related to equipment including SUTs, utilities, and facility etc.
·  Maintain a state of inspection readiness.
·  Provide input to the development of personal performance goals and departmental objectives.
·  Collaborate with Management to establish and meet targets and timelines.
·  Manage competing priorities.
·  Identify, design, and implement process and system improvements.
·  Apply advanced theory, technical principles, and expert judgment to address a broad range of difficult problems.
·  Troubleshoot and direct the resolution of Validation issues by fostering effective interdepartmental and cross-functional partnerships.
·  Train personnel and internal customers on relevant business processes.
·  Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
·  Be accountable for behaviors as described in Genentech's Core, Common, and Critical Competencies.
·  Carry out responsibilities in accordance with the company policies and procedures.

Specific Job Responsibilities

·  Responsible for developing validation strategy and coordinating validation activities required to complete large scale validation projects (equipment including SUTs, utilities, and facility etc.) in support of the SSFP operations according to the Genentech quality and safety policies, SOPs, and cGMP regulations.
·  Manage the validation deliverables of these projects (equipment including SUTs, utility, and facility etc.) ensuring new equipment and systems are implemented within predetermined timelines and financial forecasts, escalating any potential misses and develop remediation plans when possible.
·  Lead cross functional teams/initiatives and act as individual contributor to drive validation activities, change control and improvement projects, including projects aimed at improving Right-First-Time performance, and value capture projects to improve yield, reduce cost, or lower our processing cycle times.
·  Review/approve validation deliverable documents like protocols, plans, etc., execute studies and report results/conclusions utilizing sound science-based rationales and engineering principles to support SSFP qualification projects as required per current Good Manufacturing Practices (cGMPs).
·  Author, review and approve Change Control documentations for complex validation, equipment, facility/utility and/or automation changes. Manage on-time implementation and close-out to meet project, production and supply timelines.
·  Prepare source documentation for regulatory filings as assigned, may support and serve as a lead SME during regulatory inspections related to investigations, projects and validation.
·  Coordinate the collection, testing, and analysis of samples and reporting of results required per validation protocol.
·  Procure and manage contractor support for outsourced validation assignments.
·  Provide input into the design and presentation of department performance metrics.

Qualifications

This position can be filled as an Engineer or a Manufacturing Technical Specialist. The job family will depend on the qualifications of the selected candidate. Requirements include the following:

·  Bachelor's degree in Engineering, Life Sciences, or related discipline.
·  3+ years of relevant experience, or combination of experience and relevant advanced degree, focused on validation preferably in biopharma manufacturing role.
·  Strong project management capabilities.
·  Technical expertise to define validation approaches and execution of system validation activities in accordance with cGMP and applicable regulations, procedures and industry guidance.
·  Knowledge and experience with implementation of single use technologies (SUT) including design, testing, and qualification of SUT is preferred.
·  Ability to independently evaluate technical situations and propose potential solutions.
·  Ability to communicate clearly and professionally in writing and verbally.
·  Basic understanding of data and statistical analysis of validation test results.
·  Flexibility with work hours to meet business needs.

·  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.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.