Christopher Wimmer Email & Phone Number

Raleigh, Nc, Us

Bagsværd, Dk

• Initiated new modelling domains and maturing capacity flowsheet modelling domain at Clayton API site. • Established and managed a prioritized, site-wide project portfolio for all modelling activities.• Provide technical input and guidance on modelling projects to ensure scope is maintained and timely delivery of analysis and recommendations.• Developed student pipeline with local universities to hire entry-level engineers for the modelling team and for the API facilities.• Focus on team member's performance and development opportunities.

Bagsværd, Dk

• One-year assignment to Denmark to onboard and train as a Process Systems Engineer (PSE).• PSE is the scientific discipline of integrating scales and components describing the behavior of a physicochemical system, via mathematical modelling, data analytics, design, optimization and control.• Developed flowsheet simulation models for API factories at Clayton site using PSE principles.• Used simulation models to perform analysis for capacity ramp-up, production planning, detailed scheduling, and manning forecasts.• Provided recommendations and aiding decision-making for operations, project office, supply chain, and site leadership.• Developed the business case for creation of process modelling and simulation team at Clayton API site.

Bagsværd, Dk

• Responsible for design and development of stainless steel tanks, adhering to user requirements.• Managing vendor purchase orders of stainless steel tanks in regards to cost, scope, time.• Collaborating with Engineering Consultant and equipment vendors by conducting weekly design meetings, vendor visits, design reviews, design qualifications of process equipment, and executing equipment/automation Factory Acceptance Testing.• Developing automation functional specifications for process equipment (Syncade, DeltaV).• Designing of production electronic batch reports and electronic batch release systems.• Short-Term Assignment to Denmark to support qualification of new UF/DF skid.

Bagsværd, Dk

• Three-month assignment to Denmark at production facilities to learn API processes.• Development of Risk Assessments, User Specifications, P&IDs for greenfield API facility.• Department representative for EHS responsible for conducting OSHA process hazards analyses.• Development of project-wide Quality Risk Assessments to mitigate contamination risks and implement closed system principles into design.

Rahway, New Jersey, Us

Deviation Management• Investigation of deviations, process improvement and optimization.• Use Root Cause Analysis to determine root cause of deviations.• Trending analysis, providing metrics on recurring deviations.• Implement CAPAs that reduce deviation generation rate.• Determine potential downstream effects and impact to product quality.• Use technical writing skills to communicate the investigation according to GMP and GDP standards.• Interface with multiple departments: Operations, Engineering, and Quality Assurance.

• Product development of tissue engineering devices.• Used SolidWorks to design products for rapid prototyping and injection mold manufacturing.• Designed and executed mechanical and biological experiments to test development of products.• Authored user instruction manuals and technical reports .• Interacted with customers at trade shows and by providing customer support for products.

• Learned tissue culture techniques in order to grow and maintain human tendon cells for bioartificial tendon research. Including good laboratory practices, sterile technique, media preparation, cell feeding and splitting.• Became familiar with industrial and engineering practices for developing new tissue engineering components/systems. Including investigating material properties, electrical component assembly, minor part design, calibration testing, software testing, and following/writing protocols.

• Processed and managed Biosafety Level II specimens.• Used lab inventory system (BSI), standard laboratory equipment, and cryogenic freezing.