Process Engineer I (Formulations)

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

Always innovating, we bring together dedicated people and diverse perspectives from across our global network, empowering each other to keep breaking new ground. We are Roche.

The Opportunity

As Process Engineer I (Formulations) you will work with a cross-functional team to plan, execute, and implement changes to existing products, scale-up of products, and transfer of new products in Formulations.

This position is responsible for evaluating formulations, scale up and validation procedures and statistical techniques; analyzes production limitations and standards, and revising specifications when required. Writes validation protocols, leads internal improvement projects, and updates documents as needed.

This position also assists with nonconformance investigations, process deviations, Corrective and Preventive Actions (CAPAs), and working with quality on improvement projects.

• Perform wet chemistry formulations and support process characterization of the reagent formulation processes.

• Execute validation (IQ/OQ/PQ) protocols, test method validations, cleaning process validations, and associated activities for new or scaled up processes

• Troubleshoot formulation process issues related to yield, quality, and throughput.

• Support and perform preliminary studies, Guard Band studies, Differential Error Analysis (DEA), process development Qualification & Validation activities. Analyze and summarize data.

• Support process characterization documentation development and new process implementation. Support process improvement modification and implementation. Onboarding and qualification of new Equipment for process characterization.

• Support resolution of quality issues, NCMRs, and CAPAs by performing investigations, conducting root cause analysis, and developing, and implementing plans to resolve the quality issue.

• Perform new equipment Gage R&R, method development, IOQ.

• Draft and/or modify equipment supporting documentation such as EAN, ES, EI, PM, VLP, VLR, MWI.

Who you are

• Bachelor's degree in Chemical, Biomedical Engineering or related Scientific discipline

• Minimum of 1 year of relevant experience in formulations, chemistry, or assay development positions in the molecular biology industry field is preferred but not required.

Preferred behaviors, competencies, and qualities of the ideal applicant.

• Working knowledge of pharmaceutical/medical device cGMPs and FDA compliance is strongly preferred.

• Demonstrated ability to lead fast track investigations through analysis to outcomes for decision

• Must be proficient in the use of computer software programs such as Word, Excel, Visio, PowerPoint.

• Proficiency using statistical software such as JMP is a plus.

• Lean Manufacturing or Six Sigma knowledge is a plus

The expected salary range for this position based on California is 65,200.00 - 121,000.00 USD annually. 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 not available for this job posting.

Who we are

GenMark is now a proud member of the Roche Group, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. With the addition of GenMark to the Roche Group, syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses. GenMark's ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California.

GenMark is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.