Principal/Senior Principal Process Engineer, Visual Inspection

International Association of Plumbing and Mechanical Officials (IAPMO); Hillsboro (OR); On-site; USD 95,000 - 176,000; Full time

Job summary

An established industry player is looking for a skilled Process Engineer to enhance the visual inspection processes in their Aseptic Filling Operations. This role involves providing technical expertise, troubleshooting, and optimizing operations while ensuring compliance with cGMP regulations. You will collaborate with cross-functional teams to drive continuous improvements and support regulatory inspections. If you have a passion for engineering and a commitment to quality in the pharmaceutical industry, this opportunity will allow you to make a significant impact in a vital role that supports the delivery of life-saving medicines.

Benefits

Relocation benefits

Discretionary annual bonus

Comprehensive benefits package

Qualifications

• 8+ years in bio/pharmaceutical experience, preferably in cGMP manufacturing.
• Expertise in visual inspection systems and process validation.

Responsibilities

• Provide technical support for inspection operations and process improvements.
• Conduct root cause analyses and implement corrective actions.

Skills

cGMP regulations

Process troubleshooting

Data analysis

Problem-solving

Project management

Lean Six Sigma principles

Education

Bachelor's degree in Engineering

Pharmaceutical Sciences

Tools

Statistical tools

Job description

The Position

The 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.

The Opportunity:

We are seeking a skilled process engineer to join our dynamic team with a focus on providing day-to-day operations support for our Aseptic Filling Operations with a focus on the Visual Inspection Process of semi-finished products. As a Process Engineer, you will play a crucial role in ensuring the smooth and efficient operation of our visual inspection processes, while maintaining the highest quality standards. As a member of this team, you will work closely with cross-functional teams, including Manufacturing, Quality Assurance, and Engineering & Science and Technology, to drive process improvements, troubleshoot issues, and ensure compliance with regulatory requirements.

What you’ll do

• Provide technical expertise and support for Inspection operations, including process troubleshooting, optimization, and improvement initiatives.
• Provide technical support and expertise for drug product manual visual inspection, semi-automated Inspection, and automated inspection operations.
• Perform data gathering, root cause analysis, and performance trending to develop appropriate process control changes for complex issues.
• Perform product complaint assessments and or investigations, and other related post-market surveillance activities.
• Conduct process investigations and root cause analyses to identify and address deviations, non-conformances, and other process-related issues, implementing corrective and preventive actions as necessary.
• Utilize Lean Production System elements and methods to continuously improve Engineering tactical business processes and procedures.
• Participate in process validation activities, including protocol development, execution, and report writing.
• Support equipment qualification and commissioning activities for new manufacturing equipment or processes.
• Participate in technology transfer activities from development to commercial manufacturing, ensuring successful scale-up and process validation.
• Support regulatory inspections and audits by providing technical expertise and documentation.
• 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.
• Train and mentor team members to enhance their skills and promote professional growth.

Who you are:

• Bachelor's degree in Engineering, Pharmaceutical Sciences, or a related technical field.
• Minimum of 8+ years of relevant bio/pharmaceutical experience preferably in cGMP manufacturing or manufacturing support.
• Strong knowledge of cGMP regulations and quality systems, with experience working in a regulated environment.
• Proven ability to troubleshoot equipment issues, implement process improvements, and qualify and validate process equipment.
• Recognized as an expert with visual inspection systems, including automated, semi-automated, and manual processes in a cGMP environment.
• Proficient in data analysis and statistical tools for process monitoring and optimization.
• Detail-oriented with strong analytical and problem-solving skills, with the ability to identify root causes and implement effective corrective actions.
• Strong written and verbal communication skills.
• Ability to work independently and challenge the status quo, handle multiple projects, prioritize and delegate effectively, adapt to changes quickly, and work collaboratively on cross-functional teams.
• Demonstrated project management skills.
• Experience with qualification and validation protocols is preferred.
• Familiarity with Lean Six Sigma principles and continuous improvement methodologies is a plus.

Please note this role is eligible for relocation benefits.

The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $95,000 to $176,000 for the Principal Engineer level and $112,900 to $210,000 for the Senior Principal Engineer 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.

Link to Roche/Genentech 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.