Samuel Willis Email & Phone Number

United States

Lawrence Township, NJ, US

Indianapolis, Indiana, US

· Engaged with site leadership and project stakeholders to increase CAI site presence by 125% following a self-defined business development plan· Developed project proposals, scopes of work, budgets, and timelines for all client site projects· Maintained a site-specific staffing pan to ensure team members are fully billable while simultaneously catering to.

Indianapolis, Indiana, US

· Managed 14 total projects of variable sizes overseeing $3.3MM and a team ranging from 7-9 Engineers· Generated project staffing plans, schedules, and budgets to manage scope creep and accommodate client requests· Development of project roadmaps (schedules, workflows, etc.) and providing communication to different teams.· Led meetings with the client to.

Indianapolis, Indiana, US

· Performed 129 total validation executions (IQ, OQ, & PQ) for various ATMP Equipment.· Developed 405 total validation document deliverables (VP, IA, URS, CS, IQ, OQ, PQ, RTM, SR).· Assist in onboarding new team members and teaching validation principles and practices.· Lead multiple equipment qualification projects for the validation team.· Development of.

Indianapolis, Indiana, US

· Managed the entire process of drafting, adjudicating, and pushing to approval of 119 quality impacting system requirement specifications (SRS/URS) over ~3 months· Managing the development of approximately 80 Non-Quality impacting SRS's· Acted as point of contact between Global BMS reps and the CAI team and providing input based on previous experiences.

Indianapolis, Indiana, US

· Collaborated with team to execute 10 individual Commissioning Test Protocols.· Learned the basics to operating, problem solving, and controlling equipment using DCS-DeltaV.· Gained hands on experience with both Upstream and Downstream Biotech equipment including Chromatography skids, Viral Inactivation and Neutralization Tanks, Single Use Bioreactors.

Indianapolis, Indiana, US

· Developed Preventative Maintenance SOPs for GMP systems to ensure operational safety and prolonged equipment lifetime.· Created Preventative Maintenance schedules for 323 pieces of equipment, both GxP and non-GxP, within Building CURE while managing turnover and review.· Reviewed contractor submittals for 14 GMP utilities/systems ensuring accuracy for.

Cambridge, Cambridgeshire, GB

Initiated organization change management and followed changes through to completion.Used 3D modeling of process components and prototypes to communicate with vendors.Utilized LEAN methods to ensure proper work flow and facilitate productivity.Updated SOP's and WI's to ensure Technical Team and Technicians are communicating effectively.Follow and uphold.

Milford, MA, US

Utilizing root cause analysis, I worked through investigations, CAPA’s, and client audits. While working through this semester I had the pleasure of learning AutoCad on my own to create 3D models of a future project. This project was one of a couple proposed to supervisors for potential projects to increase overall site capabilities. During all these.

Milford, MA, US

This position allowed me to learn the intricacies of the Pharmaceutical Industry. I learned about overall site capabilities, cGMP documentation, corporate culture, and all utilized processes for Oligonucleotide creation. All cGMP documentation brought me close to the validation process for cGMP machines. My most notable work was with software/hardware.

Paris, Île-de-France, FR

Overtook Process Engineering responsibilities for Nissan H61L Radiator and Condensers. This work brought me close with manufacturing skids, operation time charts, ergonomic equipment, and required validation. I quickly learned the Six Sigma technique and used the technique to increase H61L Condenser Back End savings by.5 Million through reduction of cycle.

Paris, Île-de-France, FR

Supervised Nissan Condenser Back End production while moving towards full production capabilities. I participated in morning, weekly, and monthly meetings to update project managers on progress and planned steps while learning about projects other P1 members were working on. Created work instructions for packaging techniques, Mass Spectrometer operations.

Chemical Engineering

Minor, Materials Engineering