24 days agoRoche

Quality Engineer, Method Validation

  • Hillsboro (Washington)

Job description



·  Job facts

Main Purpose of the Position:

·  Provide Quality Oversight to projects focused on the design, development and qualification of equipment into GMP manufacturing as well as laboratory
·  Ensure procedures for Qualification and Support Process reflect current GMP requirements
·  Provide Quality Oversight to projects focused on the validation of methods
·  Ensure procedures for method validation reflect current GMP requirements
·  Ensure rapid resolution of issues, including discrepancies, investigations, and implementation of effective CAPA (corrective actions preventive actions) for equipment and method validation to support operational units in the manufacturing and laboratory areas.
·  Maintain the compliance status of the assigned validation and qualification areas at a state of inspection readiness.
·  Working with multiple functions, lead solution of qualification and validation issues following cGMP regulations and Genentech standards.

Job Duties/Responsibilities:

·  Working with site and corporate level functions, serve as the Quality representative in the design and implementation of area and cross-functional projects and initiatives.
·  Support continuous improvementand implementation of best practices for site and network qualification and validation through benchmarking with Genentech and industry groups in collaboration with local and corporate level functions.
·  Troubleshoot and support the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
·  Support the user requirements for production and laboratory equipment and support purchasing
·  Be accountable for behaviors as described in Genentech's Competencies.
·  Provide input into the design and presentation of validation performance metrics.
·  Must be able to work independently, organize and manage projects by demonstrating progress against defined milestones and schedules.

Technical Duties/Responsibilities:

·  Provide Quality oversight (including technical requirements and regulatory expectations) of site qualification and validation efforts.
·  Review and approve qualificationand validationdocuments (e.g. Qualification Master Plans, Project Plans, User Requirements, Protocols, Qualification Deviations, Summary Reports, etc) for cGMP and technical content.
·  Provide technical and quality qualificationand validationassessment and approval for engineering and process changes.
·  Collaborate with departments to ensurerisk management,qualificationand validationactivities are executed compliantly, with efficiency and effectiveness
·  Participate in the risk stages of procuring new equipment.
·  Collaborate with departments to ensure risk management and qualification activities are executed efficiently and effectively.
·  Provide input into investigations with potential qualificationand validationimpact.
·  Provide input and collaborate with other site/functional units and Corporate on qualification and validation standards and procedures.
·  Apply knowledge of validation principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory agency expectations and industry trends.

Qualifications: Education, Experience, Knowledge and Skills:

(Minimum requirements)

·  B.A. or B.S. degree (preferably in Engineering or Life Science) and at least six years'experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience.
·  Laboratory design and start-up experience is preferred
·  Knowledgeable of engineering principles and concepts applicable to Process as they relate to system performance, regulatory agency and Genentech requirements.
·  Sound knowledge in Qualification and method validation
·  Knowledge of Risk Assessment Methodology (PHA, FMEA, FTA).
·  Ability to work collaboratively in cross-functional teams to achieve milestones and goals.
·  Sound knowledge of EU and US cGMPs and applicable validation guidance.
·  Ability to interpret and relate Quality standards for implementation and review.
·  Ability to make sound decisions about quality and technical subjects.
·  Ability to communicate clearly and professionally both in writing and verbally.

·  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.