System Owner (Harvest)

Job description

·  Job facts

The Harvest System Owner (HST SO) will be reporting to the GMP Services Upstream Manager. The System Owner will be accountable for the availability of the Harvest Centrifugation, Depth Filtration, and Harvest Collection storage systems to manufacturing that will operate in safe and quality compliant manner. The HST SO will be accountable for all Disc Stack Centrifuges, Depth Filters, Polishing Filtration, and Harvest Tanks located in CCP1 and CCP2 plants. The HST SO will coordinate all activities related to the Centrifugation, Filtration, and Harvest Fluid Collection systems design, operation, troubleshooting with Quality Validation, Safety / Health / Environmental, Facility & Engineering, Maintenance, and Manufacturing groups.

The HST SO will ensure an integrity, maintainability, reliability, and fit for use performance of the Centrifuge, Harvest Cell Culture Fluid (HCCF) Collection, and Depth Filter systems with all associated support equipment, instrumentation/analyzers, piping and valves. The HST SO will lead a team of specialists for equipment, automation, and documentation. The HST SO shall be accountable for the training of the Manufacturing personnel involved with operating Harvest separation equipment. and will provide leadership decision making in process and problem solving. The HST SO will be accountable for ensuring that capital projects deliverables related to the Bioreactors are technically viable and consistent with user/operational requirements.

The HST SO shall serve as a Subject Matter Expert on the Disc Stack Centrifuge and Depth Filtration Equipment Systems and associated processes with an in depth knowledge of the equipment functionality.

Requirements:

Education:

·  Bachelor Degree in Chemical, Mechanical, or Bio-Chemical Engineering is preferred. Degrees in other Engineering fields as well as in Scientific disciplines (e.g. Chemistry, Biology, Physics) are considered.

Experience

·  10-12 years of design and/or operational experience

Knowledge/Skills/Competencies

·  Demonstrates a complete quantitative and qualitative understanding of process engineering principles and concepts with an ability to provide solutions to complex technical problems in the bio-pharmaceutical processing
·  Complete technical, design, and operational competence of Centrifugation and Depth Filtration System Class (es) within area of responsibility, and good understanding of complete Mammalian Cell Culture Process Upstream, Downstream, Process Supports and Utilities functions
·  Experience with manufacturing processing equipment that includes automated systems as fermentation and bioreactors, harvest centrifuges, depth filtration, process tanks, clean-in-place & steam-in-place systems, hydraulics and heat transfer, instrumentation and controls, hygienic design / BPE principals
·  Capable of providing creative, out of the box approaches to design and operating challenges
·  Proven ability to understand Project Management concepts and execution phases / technical deliverables for each phase
·  Working knowledge of applicable Quality Systems (e.g. Clean Utilities, sampling /QC)
·  Working knowledge of cGMP practices, experience of working in a cGMP environment
·  Excellent written, verbal, and presentation skills with proven ability to use market available software

Roche is an equal opportunity employer.
Manufacturing, Manufacturing > Production Engineering

·  Who we are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

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.