QC Equipment Qualification Engineer
Posted on: November 23, 2022
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
* 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
* May support method validation activities as assigned.
* Perform other tasks as requested by the HTO ASAT management to
support QC laboratory operations.
* BA, BS or Associates Degree in relevant discipline (e.g.:
engineering, computer science, chemistry)
* At least 5 years of relevant experience in the pharmaceutical or
* 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
* Experience with Computer System Validation and Data Integrity is
* Proven ability to communicate clearly and professionally both in
writing and verbally
* Ability to work independently yet collaboratively and in a hybrid
* If required, you'll be asked to provide proof that you're fully
vaccinated upon your start date
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
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