Emily Welker Email and Phone Number

Responsible for the design and implementation of integrated process related projects including design, process equipment selection and installation specifications, vendor and contractor management, process electrical / control and instrumentation design integration as well as construction management and start-up support.Responsible for managing all aspects of integrated design build process related projects in the range of $2MM to $10MM.Accountable for all aspects of client development and project execution including: proposal development and presentations, project team leadership, project budgets and forecasting, vendor/contractor management, equipment procurement, schedule management, project engineering, and site management/installation support.Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team

Developing and executing project tasks and deliverables. Provide process engineering technical support and leadership to develop and implement process concepts and designs on technically complex projects Responsible for coordinating with other disciplines including architects, mechanical, I&C, and electrical engineers and also client personnel to ensure the design requirements are met on various project sizes. Projects consist primarily of pharmaceutical, biotechnology, or industrial process projects including both existing renovations / retrofits and new construction.Responsibilities Include:Gathering process data and develop project requirements.Directing the development of mass balances and detailed equipment lists for complex processes.Developing process description narratives, process flow diagrams, and P&IDs.Working directly with facility planners to layout the process needs including space, adjacencies, and flows.Working with the project manager and other discipline leads to ensure process deliverables and all the necessary details related to the process are delivered on time, fully coordinated, and within the project budget.Researching process equipment providers and making recommendations / selections based on client and project requirements.Writing process equipment specifications for complex equipment.Writing testing requirements and attending factory acceptance tests (FATs) for equipment.Following projects after construction documents are issued and reviewing submittals, answering RFIs, and making field visits to verify progression of process scope is proceeding per the intent of the design.Directing activities of CAD and Designer support staff.Representing CRB with external partners and clients and developing key relationships throughout the industry including participation in industry organizations, writing papers/articles, and speaking and presenting.Mentor Process engineers.

IG Fill/Finish Support the aseptic vial filling process equipment to bring Shire additional capacity for testing, purification, and fill/finish for its biologic medications Leadership and support role as and Engineering representative for specific unity operations as part of the Filling/Packing areas Developing, evaluating and implementing cost-effective equipment improvements in a fast-paced cGMP, biotechnology environment  Start-up, de-bugging, optimization, commissioning, validation, conformance lots, routine manufacturing, contractor and consultant supervision and creating and executing change control documentation

The Production Engineer IG is responsible for on-shift operational support of the IG Manufacturing Process and to support ramp up activities.Primary responsibilities of this role include:Troubleshoot and provide timely resolution to technical issues in support of ramp-up and steady-state operations of a highly-automated pharmaceutical manufacturing facility. Scope of support will include:IG process anomaliesProcess equipment (Vessels, SIP Skids, Vial Filling equipment, Isolator, Chromatography, COP washers, CIP skids, )Distributed Control System (DeltaV) and Process Logic ControllersManufacturing Execution System (Siemens Simatic IT)Automation hardwareIn Process Testing labSafety and quality investigationsContinuously improve manufacturing operations by:Reducing manufacturing events, user interventions, and batch record alertsIdentifying and developing opportunities to reduce cycle time, error proof operations, and eliminate wastePerforming operational assessments to ensure proper processes, procedures, tools, and training are in placeInvestigating and resolving issues assigned from the departmental issues logSupporting Process Unit Team projects and Continuous Improvement effortsActively support information sharing and learning between team members by:Lead Knowledge Transfer training with manufacturing staffCoach manufacturing staff while partnering with them to resolve technical issuesDevelop troubleshooting guides for common problemsShare process knowledge with colleagues across-shift

Worked on site at SHIRE (formally Baxalta, formally Baxter) in Covington, GA executing Start Up and Post S/C activities.CRB's process engineers provide in-depth knowledge and experience to the unit operations of a wide variety of advanced technology processes. We possess a deep understanding of the technical drivers that impact the engineering solutions and success of your project.By combining our broad range of process engineering expertise with the application of dynamic simulation techniques, CRB consistently provides practical design processes that operate efficiently, sustainably and economically. Our process engineers provide production solutions that are sharply focused on output, energy and safety. We are committed to helping you increase your return on investment, improve production yields and enhance capabilities.Our process engineering capabilities include: -Chemical engineering-Packaging engineering-Process simulation-Process architecture-Lean Design / Plant Optimization-Process design and scale-up-Superskid & Module Design-Packaging Engineering / Integration-Warehouse & Material Flow Analysis-Risk Assessments & HazOp Reviews-URS & Equipment Specifications-Virtual Design & Construction/BIM/3D Design & Isometrics-Ergonomic Studies-Sustainability evaluations-Turnkey solutions and project management-Coordination of specialty contractors and installers-FAT / SAT / Start-up services-Created a new vent deflector design that was implemented throughout the facility to resolve issue involving water leakage through the vent lines on vessels. -Field work with Buffer Prep, CIP/Cleaning Validation, and Fill/Finish, (Start up, Equipment Design, SCD/UCD testing, Spray Coverage, Post S/C work, Validation, Process Improvement, Sterile Sampling)-Worked with PI Data Historian, DeltaV (operations, troubleshooting), BioVoke, Unifier, BPLM, Pipe-Flo, etc. -Albumin COP lead for validation of washers

Help execute Installation Verifications (IV) and Operational Verifications (OV) within the Immunoglobulin (IG) department. Help out with start-up testing in the Buffer Prep area. Point of contact in the field during execution to coordinate equipment usage between different Baxalta teams and construction contractors. Ensure equipment usage is communicated and logged. Help track execution activities and issues. Help coordinate communication and issue resolution between execution team and supporting groups (utilities, maintenance, and automation). Issue shift report and help report progress in area meetings. Support safety needs and walks of areas. Report safety incidents, perform safety walks, ensure JHA safe guards are in place, ensure signs are places and removed accordingly. Support IG field activities.

Global BioScience & BioPharmaceuticals Company with a passion for improving lives & advancing innovative therapies.

Engineering Thermodynamics grader/lab assistant