Manufacturing Technical Specialist

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.

Roche is dedicated to evolving the practice of medicine and helping patients to live longer, better lives. Our operations are critical to the success of our company and our impact on society. As a Manufacturing Technical Specialist, you will be part of an industry-leading organization helping patients to obtain on-time and reliable diagnostics. Doing now what patients need next.

The Manufacturing Technical Specialist contributes to producing reliable antibodies, raw material products and supplies with effective operations in an empowered organization. As part of a dynamic team, the Manufacturing Technical Specialist is responsible for collaborating with their team to manufacture antibodies and perform a wide variety of complex tasks related to manufacturing operations.

Manufacturing Technical Specialist recognizes and elevates safety, quality, and product problems, contributing to the achievement of production goals. Utilizes validated software and systems to maintain processes, batch records, and inventory control. Ensures all production related documentation is in compliance with quality system regulations. May be responsible for low complexity training of new employees and sharing best practices. They must have good communication and organizational skills and the ability to identify opportunities that would drive the business forward.

Your Opportunities

Production (80%)

Executes the process of antibodies manufacturing of varying complexity and in accordance with production manufacturing records, operating procedure requirements to produce finished intermediates, antibodies and while meeting production targetsCapable of basic transactions within highly complex systems and controls in a regulated manufacturing environment (e.g. receive, process, build product/materials, facilitate material availability, SAP

transactions/confirmations).

Runs sequences of operation, including: setup, operation, and cleaning; Monitoring and performing basic aseptic techniques in cell culture and troubleshootingParticipate in the execution of protocol/validationsAbility to be a subject matter expert (SME) in one or more areas of production such as Hybridoma and

Recombinant both areas.

Safety and Quality (10%)

Maintain Right to Operate and ensure that all processes are performed in a safe and healthy manner;

Address and escalate any potentially unsafe hazards; Provides feedback during investigation of safety

hazards, incidents and near misses using safety reporting tools.

Perform tasks/transactions in the quality system to ensure we achieve our quality objectivesUnderstand the expectations of audit readiness (OSHA, FDA, QSR, GMP, ISO, etc.); may be required to

Answer Questions About Processes On The Spot.

Maintain accurate and complete system transactions ensuring material traceability, and inventory accuracy (e.g. receipt, storage, issuance of materials, and other inventory transactions)Provide feedback on NCR investigations, reworks, and corrective actionsAdhere to 95% or above internal training compliance

Continuous Improvement (5%)

Responsible for 6S activities, environmental monitoring and developing/following standard work; identifies and implements process improvements and continuous improvement initiatives utilizing lean toolsParticipates and contributes in the daily tier meetings and monthly staff manufacturing meetingsMay participate in the collection of data for daily metrics purposes and to support operational excellence initiatives and improvements

Teamwork and Collaboration (5%)

Proactively collaborates with peers in other shifts/functions to ensure daily targets are achievedAssist in the successful onboarding of new employees and contractors

Other duties as assigned.

Who are you?

Education/Experience

Bachelor's Degree in Science required2 years relevant work experience, preferably in GMP environmentExperience with automated manufacturing equipment in a regulated environment, requiredExperience with validated software systems used to maintain Quality, Inventory, and Processes, requiredFamiliarity with sensors, motors, cylinders, etc., and with use of hand tools and test equipment, required

Knowledge Skills and Abilities

Demonstrated experience with Lean / Continuous ImprovementExperience with Google products (gMail, gSheets, gDoc, etc), preferredExperience with SAP requiredAbility to read, write and comprehend EnglishAbility to work with cross-functional teamsAbility to be agile and accurate in a high-volume environmentStrong organizational skills, planning skills and attention to detailStrong communication skills - written, verbalStrong critical thinking, problem solving and analytical skillsExcellent time management skills to manage multiple tasks and competing timelinesAbility to use the technology associated with the industryAbility to use precision toolsAbility to have prompt, regular and reliable worksite attendance

Physical conditions and PPE requirements

The physical demands described are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required to stand, walk, sit, kneel, bend, crouch for a combined 4 or more hours per dayRequired repetitive, consistent movements of the wrists, hands, and/or fingersRequired to have good near visual acuity to perform activities throughout the processes in the assigned areaMust be able to wear and work in personnel protective equipmentThis is an essential position supporting the organizational goals requiring attendance during emergency or

Relocation benefits are not available for this job posting.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. Our integrated staining, workflow management and digital pathology solutions optimize laboratory efficiency to reduce errors and support diagnosis for pathology professionals. Together with Roche, Ventana is driving personalized healthcare through accelerated drug discovery and companion diagnostics.

Roche 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.

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.

Roche 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.