Principal Manufacturing Technician, BioProcess Operations
Company: Hoffmann-La Roche Ltd
Posted on: November 19, 2021
Please note this position could be either a Day or Night Shift
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!
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.
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.
* 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
* 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
* Use of automation and manual processes to perform production
* 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
* 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
* 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.
* 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
* Perform Solution Preparation activities (media and buffer
* Clean, assemble, and sterilize equipment using glass washers and
* Perform automated CIP and SIP of fixed equipment.
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
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
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
* May work with hazardous materials and chemicals.
Keywords: Hoffmann-La Roche Ltd, Vacaville , Principal Manufacturing Technician, BioProcess Operations, Education / Teaching , Vacaville, California
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