Manager, Process Sustaining Engineering

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

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.

As the Manager, Process Sustaining Engineering you will be responsible for the direction and coordination of Manufacturing Technical Operations functions for process engineering, characterization and development. You will manage the process development team to develop optimized processes for manufacturing ePlex consumables and introducing new ePlex products. You will have a strong working knowledge of all elements that go into the creation of an ePlex consumable. You will foster a strong attitude of collaboration and work closely with all other groups within the organization to develop and implement improvements for manufacturing success, robustness and delivery of quality product to the end user.

The Opportunity

• You manage the process sustaining engineering team, including technical oversight, professional development, and hiring qualified personnel. You lead a team of technical experts to support manufacturing and translate business requirements into process changes in support of product and manufacturing strategies. This includes providing supervision and leadership to the recipe authoring group within the MES Systems.

• You will manage day-to-day operations focused on resolving complex equipment issues, improving throughput yields, and driving overall equipment efficiency (OEE). Leveraging your expertise in equipment, you will offer hands-on troubleshooting support and deliver technical training to engineers, fostering a culture of continuous improvement.

• You will track, trend, and report key performance indicators (KPIs) such as Mean Time to Repair (MTTR) and Mean Time Between Failures (MTBF), leading initiatives to enhance operational efficiency. 

• You serve as Subject Matter Expert for validations (IQ/OQ/PQ/PPQ), new equipment testing (URS/FAT/SAT), test method validations, manufacturing on reagents, supporting development, investigations, specification development, process improvements, design control, new product development, regulatory filings, technical documents, and inspections.

• You work with suppliers and contract manufacturers on tech transfer, process installation, process qualification, and ongoing manufacturing oversight.

• You ensure ongoing technical support for all processes both internally and/or at contract manufacturing sites and directing global initiatives and cross-functional teams of subject matter experts in manufacturing.

• You drive innovation and communication of latest industry trends and best practices for process design and manufacturing to ensure consistency.

Who you are

• You have a Bachelor's degree with an engineering or scientific focus

• You have 5+ years of operational or engineering experience in a Biotechnology, Medical Device or Pharmaceutical manufacturing environment.

• You have experience driving and leading projects with cross functional influence.

Preferred

• You bring over 3 years of direct experience in managing and leading technical teams, specifically overseeing engineers and other technical professionals.

• You have demonstrated knowledge of in vitro diagnostics and biotechnology device manufacturing and experience establishing and maintaining robust validation and process control strategies with Strong Lean Six Sigma or alternate continuous improvement skills for root cause analysis. An understanding of design control elements required for medical or in-vitro diagnostics devices is required. 

• You have experience with reagent formulation, test method development, dispensing, and component subassembly processes.

• You are knowledgeable of cGMP and 21 CFR part 11 and supporting manufacturing in an FDA regulated environment.

• You understand product development processes, design transfer experience, and design for manufacturability.

• You have experience with design/process characterization methods (DOE) and analysis (JMP, Matlab, other), analytical test method characterization and validation, Statistical Process Control (Six Sigma)

• You are knowledgeable of risk management methods (FMEA), problem resolution methods (Fish-Bone, 5 Whys etc), non-conformance and deviation management

• You are able to apply basic biologic principles including nucleic acid sample preparation and PCR amplification to understand assay performance on the consumable platform.

• You have advanced experience with root cause analysis, design of experiments, and data analysis.

Relocation Assistance is not available for this opportunity.

The expected salary range for this position based on the primary location of Carlsbad, CA is $113,900-$211,500.  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

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.