System Owner (Chromatography)

Job description

·  Job facts

The Chromatography System Owner (CHROM SO) will be reporting to the GMP Services Downstream Manager. The System Owner will be accountable for the availability of the Chromatographic separation systems to manufacturing that will operate in safe and quality compliant manner. The CHROM SO will be accountable for all Bay 1 (Affinity), Bay 2 (Ion Exchange), Bay 3 (Viral Nano-Filtration), Bay 4 (Hydrophobic Interaction) chromatography Liquid Handling Skids (LHS), Columns, Column Packing, and Product Collecting Pool Tanks located in CCP1 and CCP2 plants. The CHROM SO will coordinate all activities related to the Chromatography systems design, operation, troubleshooting with Quality Validation, Safety / Health / Environmental, Facility & Engineering, Maintenance, and Manufacturing groups.

The CHROM SO will ensure an integrity, maintainability, reliability, and fit for use performance of the Chromatography systems with all associated support equipment, instrumentation/analyzers, piping and valves. The CHROM SO will lead a team of specialists for equipment, automation, and documentation. The CHROM SO shall be accountable for the training of the Manufacturing personnel involved with operating LHS, Columns, Column Packing, and Pool Tanks. and will provide leadership decision making in process and problem solving. The CHROM SO will be accountable for ensuring that capital projects deliverables related to the Chromatography Systems are technically viable and consistent with user/operational requirements.

The CHROM SO shall serve as a Subject Matter Expert on the Chromatography systems' Equipment 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 Chromatography 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 chromatography LHS skids and columns, column packing, in-line buffer dilution, filtration, process tanks, hydraulics and heat transfer, clean-in-place & steam-in-place systems. 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.