Principal Quality Validation Engineer

Genentech; Oregon, Hillsboro (IL, OR); On-site; USD 88,000 - 163,000; Full time

Job summary

Ein innovatives Unternehmen sucht einen erfahrenen Fachmann in der technischen Validierung, um die Qualität und Effizienz in der Arzneimittelproduktion zu gewährleisten. In dieser Rolle werden Sie die Verantwortung für die Überprüfung von Validierungsdokumenten, die Durchführung von Qualitätskontrollen und die Leitung von Projekten übernehmen. Mit einer Kombination aus analytischem Denken und tiefem Fachwissen werden Sie entscheidend zur Entwicklung neuer Ansätze zur Lösung komplexer Probleme beitragen. Diese Position bietet Ihnen die Möglichkeit, in einem dynamischen Umfeld zu arbeiten und einen bedeutenden Einfluss auf die Lebensqualität von Patienten zu haben.

Benefits

Relocation benefits

Discretionary annual bonus

Comprehensive health benefits

Qualifications

• 8 Jahre Erfahrung in der Branche oder 5 Jahre mit einem Master.
• Fachwissen in technischer Validierung oder Qualitätsvalidierung.

Responsibilities

• Überprüfung und Genehmigung von Qualifikations- und Validierungsdokumenten.
• Leitung von Projektteams zur Lösung komplexer Probleme.

Skills

Qualifikation und Validierung

Analytisches Denken

Projektmanagement

GMP-Standards

Education

Bachelor's Degree

Master's Degree

Job description

The Position

Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche's commercial portfolio & pipeline products. The Operations organization at HTO is divided into 2 value streams, which combine to produce millions of units of life-saving medicine every year for patients around the world.

The Opportunity:

In this role, you will apply knowledge of qualification and validation principles, manufacturing processes, quality systems, engineering design fundamentals, health authority expectations, and industry standards. You will review and approve qualification and validation documents, perform quality oversight of equipment, facility, utility systems, GMP computerized systems, drug product manufacturing processes, cleaning, sterilization, and analytical methods. This includes tech transfer oversight, new facility expansions, large construction projects, and the adoption of digital technology.

• You will develop new approaches to complex problems, potentially influencing others to change their viewpoints and leading problem-solving efforts through coaching conversations.

• You will work independently within broad guidelines and policies, seeking guidance only in the most complex situations.

• You will serve as a best practices/quality resource on significant matters related to policies, programs, capabilities, and long-term goals.

• You will lead sub-streams or participate in global/large cross-functional project teams to solve complex problems using analytical thinking, tools, and judgment to identify innovative solutions for Roche.

• You will address complex issues where analysis of situations or data requires in-depth evaluation of variable factors, including inter-organizational impacts.

• You will exercise judgment based on multiple sources of information and interactions with peers and cross-functional teams.

Who you are:

• You hold a Bachelor's degree with 8 years of industry experience or a Master's with 5+ years.

• Industry experience preferably in technical validation or quality validation.

• You have in-depth specialist knowledge of your job discipline and broad knowledge of related disciplines.

• You are recognized as an internal expert in your discipline, with deep skills across multiple areas.

The expected salary range for this position in Hillsboro, OR is $88,000 - $163,000. Actual pay will depend on experience, qualifications, location, and other factors. A discretionary annual bonus may be available. This position qualifies for benefits detailed at the link below.

Link to Roche/Genentech Benefits

Relocation benefits are available.

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Genentech is an equal opportunity employer. We promote and treat all employees and applicants based on merit, qualifications, and competence, prohibiting unlawful discrimination based on protected statuses or other laws.

If you need accommodation during the application process due to a disability, please contact us via the Accommodations for Applicants form.