Principal Process Engineer, Packaging

Genentech's Hillsboro Technical Operations (HTO), located in Hillsboro Oregon, is Drug Product manufacturing (Component Prep & Compounding, Liquid/Lyophilized Filling, Automated/Manual Inspection, Packaging/Finished Products and Distribution). This location is currently experiencing a period of growth, with a variety of opportunities to support optimization of our existing processes, as well as the delivery of new capabilities and technologies. We are a key aspect in a world-wide network of industry leading expertise and high performing pharmaceutical manufacturing facilities. Our work is critical in ensuring we reliably supply medicine to the millions of patients who currently depend on us, as well as reaching new patient populations.

The Opportunity:

As a key member of the MSAT, Finished Goods team, you will focus on creating and sustaining the validated state of packaging systems, processes, and products, while maintaining the highest quality standards. You will work closely with cross-functional teams, including Manufacturing, Quality Assurance, and Engineering & Science and Technology, to implement process improvements, and ensure compliance with regulatory requirements.

• You will engage in technology transfer activities from development to commercial manufacturing.

• You will develop, document, and implement validation strategies for packaging systems that are compliant, efficient, and ensure the manufacture of quality product.

• You will ensure a risk based approach is integrated into the qualification lifecycle methodology.

• You will manage lifecycle documentation associated with the packaging manufacturing equipment and ensure it is maintained in compliant state.

• You will author and execute Installation Qualifications, Operational Qualifications, and Performance Qualifications for new and changing packaging equipment, processes, and products.

• You will facilitate cross-functional risk assessments to highlight areas of risk in need of mitigation.

• You will gather and analyse data to develop and implement process control solutions for complex issues.

• You will utilize Lean Production System concepts to identify opportunities for continuous improvement of manufacturing processes and implement solutions while adhering to the established change management processes.

• You will provide technical expertise and support for Packaging operations, including process troubleshooting.

• You will complete technical assessments for manufacturing process deviations and customer complaint deviations.

• You will support regulatory inspections and audits by providing technical expertise and documentation such as validation strategy and execution.

• You will foster an environment that encourages continuous learning. Maintain expertise as necessary to stay abreast of technical and industry advancements, and best practices related to aseptic processing.

Who you are:

• You hold a Bachelor's degree in Engineering, Pharmaceutical Sciences, or a related technical field and have 4-7 years of relevant experience.

• You have significant experience working with packaging equipment and processes in a cGMP environment

• You have significant equipment lifecycle and validation engineering experience in the pharmaceutical or other regulated field

• You have significant experience authoring lifecycle documents including qualification protocols (equipment/process/product).

• You have relevant bio/pharmaceutical experience preferably in cGMP manufacturing or manufacturing support.

• You have a strong knowledge of cGMP regulations and quality systems, with experience working in a regulated environment.

• You have experience working with Lean Production System concepts to achieve results.

• You have a proven track record for the identification and implementation of process improvements.

• You are proficient in data analysis and statistical tools for process monitoring and optimization.

• You are detail-oriented with strong analytical and problem-solving skills, with the ability to identify root causes and implement effective corrective actions.

• You have the ability to work with little direction to organize and accomplish tasks

• You have strong communication and interpersonal skills, with the ability to collaborate effectively in a cross-functional team environment.

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

Relocation benefits are available for this position.

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.