QC Equipment Qualification Engineer

Company: Genentech
Location: Hillsboro
Posted on: November 23, 2022

Job Description:

The Position



Job Title: QC Validation Engineer



Department: HTO Quality Control



Job Family: Quality



Reports To: Quality Control Analytical Sciences & Technology (ASAT) and Lab Support



Type: Term, 2 year contract



At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity. We believe every employee makes a difference. We are passionate about transforming patients' lives. We are courageous in both decision and action, we believe that good business means a better world.



The focus of Hillsboro Technical Operations (HTO) is Drug Product manufacturing (Component Prep & Compounding, Liquid/Lyophilized Filling, Automated/Manual Inspection, Packaging/Finished Products and Distribution). The site has been in service for 15 years. The HTO QC laboratories have been in service for 12 years. There is a need to replace/upgrade and qualify new QC instruments (e.g. environmental chambers, spectrophotometers, particle counters, etc.) to support our growing site. The focus of this position will be to plan and execute multiple QC instrument/equipment qualification/commissioning activities within the next two years.



Responsibilities:



Primary:



* Perform qualification of laboratory instruments/equipment in accordance with Roche/Genentech Global Standards.





* Collaborate with laboratory personnel, Vendor Technician, and Instrument Service to define qualification requirements





* Author, review and execute qualification protocols and generate equipment lifecycle documents (e.g. User Requirements Specifications, Data Integrity Assessments, Operating & Administration Procedures, etc.) using Roche's electronic validation system (ValGenesis)





* Coordinate equipment purchase and qualification activities with vendors, and site support groups (e.g. procurement, Instrument Services, Production Maintenance, and laboratory personnel)





* Decommission aging instruments / equipment





* Identify business, quality, and compliance gaps and propose improvements to systems and procedures





* Review and approve peer qualification documents





* Participate in and support internal and external audits and regulatory inspections





* May support method validation activities as assigned.





* Perform other tasks as requested by the HTO ASAT management to support QC laboratory operations.







Education:



* BA, BS or Associates Degree in relevant discipline (e.g.: engineering, computer science, chemistry)







Qualifications



* At least 5 years of relevant experience in the pharmaceutical or biopharmaceutical industry





* A minimum of 2 years of experience in validation or equipment qualification is strongly desired.





* Strong PC skills is a must. Experience using Google Collaboration Tools (e.g.: gMail, gSheets, gDocs, gDrive, gChat) or ValGenesis or other workflow management systems is a plus.





* Possess sound knowledge of cGMPs or equivalent regulations with demonstrated ability to interpret and apply Quality Standards and Policies





* Experience with Computer System Validation and Data Integrity is desired





* Proven ability to communicate clearly and professionally both in writing and verbally





* Ability to work independently yet collaboratively and in a hybrid team environment





* If required, you'll be asked to provide proof that you're fully vaccinated upon your start date







Work Environment



Majority On-site, some remote work available with advanced approval by the manager. Position may involve working in a laboratory environment and use of reagents and other chemical compounds.



Relocation benefits are available for this role.



Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.



Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

Keywords: Genentech, Hillsboro , QC Equipment Qualification Engineer, Engineering , Hillsboro, Oregon