Nicholas Andersen Email & Phone Number

Denver, Co, Us

Lakewood, Colorado, United States

Engineering Manager and Technical Lead for Focus Factory 2.

Lakewood, Colorado

Support manufacturing on the flow lines for 2 high volume disposable products. Design and implement continous improvements in manufacturing.

Diligent project manager offering a proven record or success leading all phases of diverse projects. Responsible for developing and cultivating client relations and organizational partnerships while collaborating with various departments across the organization. Responsible for development and implementation of initiatives focused on meeting the goals and priorities of the client andorganization.- Manage successful completion of sterile injectable pharmaceutical projects within scope, timeline, budget, and expectations.- Oversee seamless collaboration of the internal client teams consisting of representatives from analytical development, formulation development, technical services, quality, and process validation to ensure quality requirements are met, timely issue resolution, successful product release, and ongoing process improvement.- Facilitate client needs and expectations to project team members.- Conduct project status presentations to senior leadership and facilitate team meetings.- Identify scope creep and create scope change documents with appropriate input from functional groups.- Negotiate acceptance of scope changes with client.- Responsible for revenue forecasting, project budgets, and invoice notificationsAchievements- Chosen to lead the largest project in company’s site history in terms of scope of work. Project had an aggressive timeline to ensure products success on marketplace. Project’s overall scope was $5 million dollars. The project was successful and met its aggressive timeline. Responsibilities included handling of unexpected scope changes, modifying building utilities for project’s equipment, designing new processes and managing client’s expectations.- Assigned to manage the most technically challenging projects in the project management team. - Currently managing twelve (12) different pharmaceutical products in various phases from early clinical development to process validation for commercial distribution.

Seasoned engineer responsible for cGMP manufacturing process development and design. Provided on call technical support for manufacturing to assist with equipment and process production issues.- Executed and oversaw new product development, technology transfers and a key member of process validation programs.- Designed and wrote batch records, experimental protocols, process development reports, and other technical documents.- Provided technical leadership in the design and execution of experimental studies to define critical process parameters.- Continually researched and evaluated new technology to improve and optimize manufacturing / operating practices.- Lead cross-functional teams through process troubleshooting, investigations, deviations, and CAPA's.- Accountable for establishing the operational parameters of the process, equipment and associated methods, ensuring the overall reliability of production process operations, process robustness, and performance.- Direct communication with management to recommend technical and business solutions.- Interacted with vendors and clients to design processes and transfer products to manufacturing.- Designed and wrote user requirement specifications for new process equipment.- In-depth knowledge of cGMP practices and FDA regulations.Achievements- Chosen to be Team Lead for facility expansion equipment activities related to the purchase of two new fully automated sterile filling lines. Responsibilities include primary contact for the vendors, monitor timelines/ readiness, determine the materials needed for qualification, associated costs, monitoring the budget, and providing updates about the project to executive management.- Site representative sent to overseas equipment vendor to review equipment mock-ups and factory acceptance tests.- Assigned as Team Lead and Lead Engineer for qualifying a new aseptic filling line which doubled revenue potential of the site.

Graduate student responsible for researching and developing new technology or treatments.- Created a polymeric microsphere spray system for wound coverage that prevents infection and reduces blood loss over an extended period of time.- Encapsulated a hydrophilic antibiotic in poly (lactic-co-glycoic acid) (PLGA) microspheres for prolonged release of antibiotic to prevent infection at a wound site. Encapsulated a hydrophilic antifibrinolytic agent for prolonged release to reduce bleeding at the wound site.- Developed a prototype spray system to simulate distribution of polymeric microsphere spray over spinal wound.

-Lead an interdisciplinary engineering team to design an attachable handcycle for wheelchairs.-Designed and built an affordable option handcycle for people with spinal cord disabilities or disorders.-Pitched product design to manufacturing company which was selected for further evaluation and potential product development.

Clinical Engineering Department

Responsible for maintaining and managing the hospital’s medical devices. Worked closely with doctors and nurses to ensure equipment operated safely and effectively.- Provided in room technical support during surgeries in case of equipment failure or malfunction.- Repaired malfunctioning or non-operational medical devices by troubleshooting the root cause.- Maintained and performed preventative maintenance on medical devices to ensure devices were within calibration and operated properly.- Developed a capacity model for the Clinical Engineering department, based on the incremental devices installed and utilized at the hospital. Developed a model to evaluate the number of medical devices per Clinical Engineer, to aid in staffing/manpower decisions within the department.- Worked closely with device vendors during the implementation of new equipment to ensure appropriate staff were properly trained on related aspects of the device.- Worked closely with doctors and nurses to identify and implement new devices which could improve the associated tasks.- Conducted an in depth noise abatement study, due to low scores on patient satisfaction surveys about the hospital’s median decibel level. The experimental design of the study included measuring decibel levels throughout patient sleeping areas for 24 hour time periods. Presented findings andpotential solutions to the hospital administrative board. Corrective actions were implemented within 6 months, which improved patient satisfaction.

Master Of Science (M.S.), Biomedical/Medical Engineering

Activities and Societies: Biomedical Engineering Society Local Chapter President

Bachelor Of Science (Bs), Biomedical/Medical Engineering

Activities and Societies: Biomedical Engineering Society, Mountaineering Club

Minor, Business Administration And Management, General