Brian Dallstream Phd Email & Phone Number

Chapel Hill, Nc, Us

Chapel Hill, Nc, Us

Durham, North Carolina, Us

Currently, I am working as a Project Manager and Senior Facility Engineer at KBI Biopharma, I lead all aspects of CAPEX projects ranging from $20K to $11M for facility, dirty and clean utility, manufacturing, and lab space while overseeing and collaborating with external contractors, suppliers, engineering offices, and internal departments. I deliver manufacturing and facility support to ensure pharmaceutical compliance and audit readiness. I supervise contract engineers and trade contractors in onsite modifications for equipment and facility. I train and assist engineering, maintenance, and manufacturing departments on facility-owned equipment and software. I ensure compliance with design specifications for the facility manufacturing environment to meet cleanroom classification.Highlights of accomplishment in this role include:➙ I directed full lifecycle engineering projects from conception to finalization while completing key deliverables within strict time, quality, and budget constraints.➙ I built and promoted a culture of performance excellence by leading a team of junior engineers and interns on pharmaceutical quality design, clean utilities, and building automation system design and implementation.➙ I developed risk and root cause analysis, change control, corrective and preventative action (CAPA), and deviation procedures using advanced quality management systems.➙ I generated quality system documentation, including user and design requirement specifications and qualification documents (installation, operation, performance, and computer).

Throughout my tenure as a Compliance Engineer at Pharmasys Compliance Solutions, I facilitated startup and medium/large pharma companies in meeting regulatory guidelines for goods production while conducting gap assessments and identifying handling inefficiencies of plans in a pre-FDA audit. I delivered contract, compliance, and quality expertise regarding production line improvements and facility remediation activities for pharmaceutical manufacturing, biotechnology, and packaging.Highlights of accomplishment in this role include:➙ I managed commissioning and qualification activities and lifecycle documentation, including Factory and Site Acceptance Testing (FAT and SAT), functional specification (FS), installation and operational qualifications (IQs, OQs), and SOPs.➙ I supported clients in regulatory issues, including GlaxoSmithKline (Aiken SC & Zebulon NC), FujiFilm DioSynth Biotechnologies, National Institute of Health, University of Tennessee, Medicago, kSep Centrifuge, Tergus Pharma, Cheisi, Sartorius, and Fresenius Medical Care.

Durham, Nc, Us

While serving as a Mechanical Engineer and Manufacturing Contractor at Tergus Pharma, I supported the company in obtaining an FDA license and growing from scratch to smooth and efficient pharma manufacturing in two years while driving process and system implementation. I developed and deployed HVAC for proper pressure flows and temperatures, and HEPA filtration. I represented the owner in terms of construction/building manufacturing for the company. I performed validation activities, including installation, operating, and performance qualifications (IQ, OQ, PQ).Highlights of accomplishment in this role include:➙ I enabled the development of manufacturing batch records by estimating scale-up procedures for products developed on the lab bench by leveraging fluid mechanics knowledge.➙ I drove large equipment purchased for the GMP workspace using scale-up functional specifications for mixers, fillers, microfluidizers, tubing crimpers, and heat exchangers. ➙ I developed and implemented facility SOPs and cleaning validation methodologies for the cGMP manufacturing space and equipment.

Taught several 5 hour introduction physics course as well as college mathematics.

Kansas City, Mo, Us

Numerical Simulation of two phase flows and aerosols. Also, help write numerical procedures for the calculation of the thermo-physical properties of foods (includes cooling and freezing times).

Kansas City, Mo, Us

Classe taught or Assisted: Mechanics of Materials, Engineering Materials, Thermodynamics, Mechanical Engineering Design, Statics, Instrumentation, Refrigeration Warehouse Design.

Landskrona, Se

Wrote an aerosol capturing procedure for the engineering technicians.

Stress Analysis

Ph.D., Mechanical Engineering & Physics

Masters Degree, Mechanical Engineering

Bachelor Of Science, Mechanical Engineering

Associate, Engineering