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 fluctuating client project schedules· Empowered project management team members to ensure project success· Fostered team member professional development and provided mentoring· Facilitated crucial conversations with both clients and team to maintain relationships and guide conflicts to peaceful resolution

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 schedule Periodic Reviews and 45 Requalifications· Developed new safety Job Hazard Analyses (JHA) to capture all safety risks associated with new tasks for the projects· Onboarded teammates and integrated into both CAI and client culture and standards · Teach team members how to use Kaye validators and temperature mapping theory/strategies· Teaching the client about CAI processes during transition between different billing strategies· Providing suggestions for future state and process improvements as deficiencies were found

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 project roadmaps (schedules, workflows, etc.) and providing communication to different teams.

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 from the Juno facility· Coordinated reviews with multiple functional groups across 4 time zones· Led SLIA development workshops with stakeholders for system classification determination

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, Single Use Pool Vessels, Temperature Control Units, Tangential Flow Filtration skids.· Gained valuable experience with P&ID's and performing walkdowns of process equipment.

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 final TOP.· Updated BSL-3/ABSL-3 HVAC annual certification documentation from 12 to 5 documents to streamline execution and acceptance of results.· Reviewed Validation documentation for 14 GMP utilities/system (including HVAC, process gases, and computerized monitoring systems) to ensure successful test execution and compliance with site procedures

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 cGMP throughout process's.Adhering to safety protocols and quality assurance teams to ensure well rounded project depth.Performed data analysis to optimize key aseptic processes.Wrote protocols for data validation, and installations in cGMP areas.

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 projects, I was continuing use of qualification and documentation of cGMP environment machines. Through this internship, I realized I thrive on fast-paced, challenging work.

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 upgrades of Lyophilizers and the qualification/validation required to bring back to cGMP production. All work of qualification/validation pushed me to be a more persistent. Switching from Automotive to Pharmaceutical allowed me to work on adapting to new situations and environments.

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 time by 35%. I taught myself how to use statistical analysis package Minitab 17 and taught three others.

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, assembly operation, and powder coat paint line. Submitted PO’s for storage racks, new fixtures, and shipping for new product validation. I developed a stronger appreciation for and commitment to collaboration and teamwork after working on a team of Project Managers, Quality Assurance, Finance, and Process Engineers.

Chemical Engineering

Minor, Materials Engineering