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Principal Manufacturing Technician, BioProcess Operations

Company: Hoffmann-La Roche Ltd
Location: Vacaville
Posted on: November 19, 2021

Job Description:

Please note this position could be either a Day or Night Shift position

At Roche, 94,000 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. We believe every employee makes a difference. We are passionate about transforming patients' lives. We are courageous in both decision and action, we believe that good business means a better world.

The focus of the Vacaville Operations Facility is Drug Substance bulk manufacturing team. We have a passion for science, technology, innovation, professional development, and diversity and inclusion. We are also deeply respected for our unique and special culture; one that centers around the people we attract and hire. Beyond the intellect, people are kind and giving. Employees volunteer their time to help each other learn new skills, and give of themselves to the larger community. Our Pharma vision is to have a greater overall patient benefit and impact. This focus includes personalized healthcare, designing the processes with the patient in mind, and improving their quality of life. We hope you consider joining our team and being a part of one of the largest biotechnology facilities in the world!

Summary

Responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environments, and maintaining areas in high state of inspection preparedness. Operates production equipment for cell culture or purification that may include culture growth, process monitoring, sampling, harvesting, purification, formulation, freeze thaw and transfer. Performs media/buffer solution preparation operations. Maintains records and clean room environment to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP). Responsible for being proficient in two or more functional areas and applying expert knowledge of mechanical, scientific principles, processes and biopharmaceutical processing equipment. Responsible to transfer knowledge to others on the team and manage process improvement initiatives in conjunction with other technicians and departments.

Job Responsibilities

Upstream Manufacturing (UM): Primary focus is the cleaning, sterilization and operation of fixed vessel systems for media preparation, fermentation, and harvest operations; perform seed train operations; perform dispensing of components; handle and aliquot hazardous materials.

Essential Duties

* Represent the department on cross-functional project teams.


* Coordinate with technology, Facilities, Engineering and SHE to optimize equipment performance.


* Process monitoring and trending across all shifts.


* Expert in business support systems (SAP, POMS, PI) and facility systems (water, CIP).


* Collect, interpret and communicate process metrics; utilize metrics to recommend improvements.


* Thorough knowledge of biopharm technology, processes and the underlying scientific concepts.


* Must demonstrate a full knowledge of both general and specific aspects of multiple manufacturing departments and processes


* Troubleshoots and investigates complex problems, works with others to implement solutions.


* Operate systems that clean and sterilize tanks and filtration systems.


* Prepare solutions for the production process.


* Review documentation and check all calculations (e.g. tickets, labels, equipment reading).


* Troubleshooting equipment and process problems.


* Comply with safety requirements, cGMP, SOP and manufacturing documentation.


* Use of automation and manual processes to perform production operations.


* Support Manufacturing to meet production demands.


* Operate automated systems for equipment operation.


* Operate manual production processes for equipment operation


* Assemble and prepare equipment for production.


* Exhibit detail oriented documentation skills.


* Communicate effectively and ability to work in a team environment.


* Exhibit professional interpersonal skills.


* Work with coworkers and supervisor to effectively troubleshoot equipment and process issues.


* Ability to implement project improvements as a part of a project improvement team


* Subject Matter Expert on the operation of manufacturing equipment in multiple areas in the plant


* All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).


* Follows established safety and environmental guidelines and procedures for all work performed. Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions. Fosters a positive safety culture in which no one gets hurt.



Supplementary Responsibilities

* Operate fermenters, centrifuges, other harvest systems and protein purifications units.


* Operate and clean fixed tank and filtration systems.


* Operate large-scale column chromatography systems.


* Operate large scale UF/DF and Freeze Thaw Systems.


* Operate small-scale cell culture areas and systems by operating cleaning, set up, and maintaining 20L batch feed fermenters; inoculating and maintaining spinner seed cultures using aseptic techniques, maintaining cell banks; and performing general seed lab operations.


* Perform Solution Preparation activities (media and buffer make-up).


* Clean, assemble, and sterilize equipment using glass washers and autoclaves.


* Perform automated CIP and SIP of fixed equipment.



Job Requirements

Education and Experience

* Required: High School Diploma


* Desirable but not required: AS/BS/BA in Biological Sciences, Physical Sciences, or Engineering or combination of college coursework and related work experience or Biotech certificate from approved program



Knowledge, Skills and Abilities

* Excellent oral and written communication skills demonstrated by communicating with other functions and management regarding resolving investigations and theory.


* Ability to lead department and/or cross-functional meetings or projects.



Work Environment/Physical Demands/Safety Considerations

* Schedule could include a non-rotating 4-day (10-hour shift), one weekend day, evening or night hours, or full off-shift hours.


* Expected to be on feet for 8 to 12 hours a day.


* May climb upwards of 6 flights of stairs a day to maneuver within the manufacturing facility.


* Lifting up to 25lbs may be required.


* Environment requires that gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. In addition, no makeup or jewelry can be worn when working in the clean room environment.


* May work with hazardous materials and chemicals.



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Keywords: Hoffmann-La Roche Ltd, Vacaville , Principal Manufacturing Technician, BioProcess Operations, Education / Teaching , Vacaville, California

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