Principal Validation Engineer, PLANT Value Stream

2 weeks ago

Hillsboro OR United States Genentech Full time
The Position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.

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 Opportunity:

This role is responsible for providing scientific and technical support to the PLANT Value Stream in support of product launches, technology transfers, and new technology introduction to the HTO site. The selected candidate will be accountable for performing activities such as Cycle Development (CD), Commissioning and Qualification, Performance Qualification (PQ) / Periodic Requalification (RPQ), Cleaning Validation (CV) and Process Validation (PV), and will closely collaborate across the site and occasionally works with other network organizations. Focus will also be placed on right first time execution and continuous improvement.

  • Provide technical and engineering expertise to support the drug product manufacturing process, as well as process/product tech transfers and/or new technologies introduction projects.
  • Author, review & approve development, characterization, validation & change control documentation, including protocols, summary reports, etc., for development and validation activities. Prepare, and review relevant sections of regulatory submissions as needed.
  • Implement and manage the detailed project plans and timelines for the execution of CD/IQ/OQ/PQ/RPQ/CV/PV/RV activities.
  • Own deviations and change records, is responsible for CAPA actions, completes small scale/validation studies, performs problem solving, & monitors operations.
  • Participate in the identification, evaluation, and implementation of new process technologies in alignment with business objectives or regulatory requirements.
  • Support Investigations and atypical events, as well as resulting corrective or preventive action implementation.
  • Coordinate and perform tactical Validation activities, including sample collection, coordinating with multi-functional support teams, retrieving data and results, completing documentation, as required per protocols.

Who You Are:

  • BS/MS in Chemical, Biochemical engineering, or related Life Science subject area.
  • Minimum 8 years of experience in Drug Product Process Engineering, Manufacturing, or Technical Services is required. Experience in the pharma/biotech industry, and working knowledge of component prep, formulation, filling, and inspection processes and equipment qualification in a regulated environment is required.
  • Knowledge of cGMPs or equivalent regulations.
  • Proven technical leadership capabilities and demonstrated project management skills.
  • Ability to work effectively and efficiently with internal teams, partners, suppliers and customers.
  • Professional level written and oral communication skills required.
  • Operational excellence and industrial engineering skills are a plus.

Relocation benefits are available for this position.

The expected salary range for this position based on the primary location of Hillsboro, Oregon is $94,200 to $175,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

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.

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