Senior/Principal Process Engineer, Filling

Genentech; Oregon, Hillsboro (IL, OR); On-site; USD 80,000 - 150,000; Full time

Job summary

An established industry player is seeking a Senior/Principal Process Engineer to enhance aseptic filling operations. In this pivotal role, you will ensure quality and efficiency in the production of life-saving medicines. Collaborating with diverse teams, you will drive process improvements and troubleshoot complex issues to maintain compliance with regulatory standards. This role offers an exciting opportunity to contribute to innovative practices in pharmaceutical manufacturing while fostering a culture of continuous learning and excellence.

Benefits

Relocation Benefits

Annual Bonus (discretionary)

Comprehensive Health Benefits

Professional Development Opportunities

Qualifications

• 5-7 years of relevant experience for Senior Engineer, 8+ for Principal Engineer.
• Strong knowledge of FDA and EMA regulations.

Responsibilities

• Provide technical support for aseptic filling operations.
• Collaborate with cross-functional teams for process improvements.

Skills

Pharmaceutical/Biologics Processing Principles

cGMP Regulations

Aseptic Filling Equipment

Data Analysis

Problem-solving

Communication Skills

Education

Bachelor's degree in Engineering

Bachelor's degree in Pharmaceutical Sciences

Tools

Statistical Tools

Aseptic Filling Machines

Lyophilizers

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 to patients around the world.

What you will do:

In this exciting position, you will focus on providing day-to-day operations support for our Aseptic Filling Operations. As a Senior / Principal Process Engineer, you will play a crucial role in ensuring the smooth and efficient operation of our aseptic filling processes, while maintaining the highest quality standards. You will work closely with cross-functional teams, including Manufacturing, Quality Assurance, and Engineering Science & Technology, to drive process improvements, troubleshoot issues, and ensure compliance with regulatory requirements. You will support other front-line engineers, providing guidance and expertise in support of manufacturing.

• You will provide technical expertise and support for aseptic filling operations (formulation, vial and prefilled syringe filling, isolators, lyophilization, and capping) and front-line engineers, including process troubleshooting, optimization, and improvement initiatives.

• You will participate in technology transfers and process validation activities, including protocol development, execution, and report writing.

• You will support equipment qualification and commissioning activities for new manufacturing equipment and processes.

• You will perform data gathering, root cause analysis, performance trending, and develop appropriate process control changes for complex issues, deviations, and product complaints.

• You will collaborate with cross-functional teams to develop and implement process improvements related to product quality, yield, and efficiency; ensuring optimized and efficient manufacturing operations, as well as compliance with regulatory requirements and industry best practices.

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

• You will consistently collaborate with manufacturing personnel and front-line engineers to develop best practices for supporting the manufacturing operation, ensuring front-line engineers are providing the expected level of service.

Who are you:

• You hold a Bachelor's degree in Engineering, Pharmaceutical Sciences, or a related field, and have the minimum years of relevant experience (Senior Engineer = 5-7 years, Principal Engineer = minimum 8).

• You have a strong knowledge of pharmaceutical/biologics processing principles, cGMP regulations, and regulatory requirements (e.g., FDA, EMA).

• You have experience with aseptic filling equipment and processes, such as isolators, filling machines, lyophilizers, and sterilization.

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

• You have excellent problem-solving and troubleshooting skills, with the ability to identify root causes and implement effective corrective actions.

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

• You are detail-oriented, with a commitment to ensuring compliance and delivering high-quality results.

The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $80,500 - $149,500 for the Senior level and $95,200 - $176,000 for the Principal Level . Actual pay will be determined based on experience, level, 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.

Please note this role is eligible for relocation benefits.

Link to Roche/Genentech Benefits

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.