Manufacturing Engineer II, System Owner (Media Prep) – Roche – Vacaville, CA

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. 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. 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!

Job Summary

The Media Prep/Hold Manufacturing Engineer – System Owner (MED SO) will be reporting to the Front Line Engineering Upstream Manager. The System Owner will be accountable for the availability of the Media Prep/Hold and Media Continuous Heat Treatment (HTST) systems to manufacturing that will operate in a safe and quality compliant manner. The MED SO will be accountable for all small and large scale Media prep, hold, and HTST systems located in CCP1 and CCP2 plants. The MED SO will coordinate all activities related to the Media processing systems design, operation, troubleshooting with Quality Validation, Safety / Health / Environmental, Facility & Engineering, Maintenance, and Manufacturing groups.

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

The MED SO shall serve as a Subject Matter Expert on the Media Prep/Hold, HTST Equipment Systems and associated processes with an in-depth knowledge of the equipment functionality.

Job Responsibilities

Leadership & People Management:

  • Leads and supervises a Media Prep/Hold and HTST systems group consisting of equipment, automation, and document control specialists

  • Coordinates and interacts with System Owners for other System Classes, Engineering; Quality / Validation; QA; Manufacturing Science and Technology group; Facility, Maintenance and Metrology; Environmental, Health & Safety (SHE); Manufacturing teams; Manufacturing Planners / Schedulers; Material Management group

  • Creates a culture of safety, quality, and continuous improvement

  • Participates and provides direction and support in project execution activities related to the System Class

  • Participates and provides guidance in Stage Gate project reviews, Site Management and Stakeholders meetings, Product Councils as related to the System Class

  • Participates and provides technical guidance to the review teams in SHE lead and QV lead Risk Analysis, Deviation and Asset malfunction investigations, process studies

  • Presents and participates in the industry-wide collaborative efforts (e.g. ISPE, PDA, AIChE) as relates to all aspects of the System Class design, installation, commissioning, operation, maintenance / inspection

Technical:

  • Accountable for the Large scale Media Prep Tanks, High Temperature Short Time pasteurization (HTST), Media Hold Tanks and Single Use Bags System Classes operational performance, availability, mechanical / structural / electrical integrity and reliability.

  • High degree of expertise in the areas of Media make-up and mixing, manipulation/handling of powder and liquid kits, hydraulics and heat transfer controls for HTST systems, Bioreactor feed operational controls and functionality, CIP/SIP

  • Knowledge of design, operation, and maintenance of Media Prep/Hold system supportive equipment and instrumentation / control elements, materials of construction selection criteria

  • System Owner will be one of the Approver of the Engineering and Equipment Turn-Over Packages

  • Coordinates, reviews and interprets operational data extracted from Batch Historian, through field observations, or compilation of study data, communicating the results to other groups and management

  • Develops Statistical Process Control models in collaboration with Process Engineering (MSAT)

  • Respond quickly and capably to emergent events that could interrupt manufacturing spearheading the initial assessment of events that have the potential to impact area safety and product quality

  • Develops and conducts training on process equipment and instrumentation / control and automation systems

  • Accountable for the correctness and checking of the Automation software updates and execution as it relates to the Media Prep System Classes

  • Initiates, coordinates, and approves the Root Cause Analysis and applicable troubleshooting for the System Class, as well addressing discrepancies and CAPA

  • Accountable and responsible for generation, review, approval, and life cycle maintenance of critical process requirement documents (e.g. Process URS, Process FS)

  • Analyzes projects’ schedules and estimates assuring the system availability and date tracking

  • Accountable for sound judgement and correctness of project critical documentation (e.g. specifications, data sheets, calculations, P&IDs / PFDs, Vendor Drawings and Turn-over Packages) that may affect the System Class performance and integrity

  • Authors new SOPs, protocols, as well as review and approve manufacturing documents

  • Coordinates Systems’ status, availability, and impact across all relevant projects and activities that may affect the system in technical, cost or schedule related manner

  • Provides oversight and approval to multiple projects implementation steps as it relates to the System Class

Job 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

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 Media Handling System Classes (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 Media Prep and Hold equipment, Bioreactors, Single Use Bag and components, 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

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Source: Indeed.com
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