Program management, engineering management for site transfers
Resume:
Professional Experience
Sr. Principal Project Eng. Simtra BioPharma 10/2025-Current
Installed and commissioned $15M aseptic isolator systems in Grade C cleanrooms to support compliant fill-finish operations.
Upgraded SCADA systems for multiple filling lines within a $5M budget, improving reliability and data integrity.
Designed, installed, and qualified laminar flow hoods for two lyophilization and liquid filling suites.
Implemented automated visual inspection across packaging lines to enhance defect detection and throughput.
Engineering Manager Kimball 4/2025-10/2025
Five direct reports and manage a team of 20 new automation, manufacturing and process engineers for automation, molding and assembly of voice activated drug delivery devices and photon surgical blades
Directed the installation of two drug substance manufacturing lines within a 300,000 sq. ft. pharmaceutical facility, overseeing a $20M capital budget and strategic planning for nine future lines and a flexible expansion platform to support scalable growth.
Senior Project Manager Amgen (Contract) 1/20/25-3/2025
Developed project plans and Power BI dashboards to support drug product programs including installations of new automated packaging lines for pre- filled syringes (PFS), autoinjectors, and on-body injector platforms for biologics and combination products.
Collaborated with cross-functional teams to align device development.
Supported technical documentation and risk assessments for combination products integrating drug vials with delivery systems, ensuring inspection readiness and regulatory compliance.
Partnered with automation houses, robot suppliers, device engineering and quality teams to implement design controls and change management processes for injectable platforms targeting U.S. and European markets.
Contributed to lifecycle planning and scalability strategies for drug-device combination products, including platform expansion for future biologic launches.
Staff Project Manager Johnson & Johnson MedTech 3/2022-1/2025
Oversaw key inventory reduction Power BI dashboards for receiving inspection, digitization projects for delivery and delivering products supporting the Corporate 10% reduction goal under the Attune, Sigma & Velys robotic arm assisted surgeries for first market launch and market expansion to the EU, Japan, Australia, and China. Projects completed 1 month ahead of projected schedule with savings of $6.6 M
Development of digital dashboards utilizing external contractors and implementing agile scrum methodologies, collaborated with cross- functional teams, ensuring GxP Standards are met, and working with software vendors to implement innovative roadmaps.
Worked with finance on setting up guardrails for comprehensive business case for Integrated business planning & long range financial planning to managed free cash flow, inventory, CapEx, CAR, OpEx and profits.
Identified requirements for international and domestic projects, across all functional groups, to manage expectations throughout the project life cycle.
Managed project budget initially set for $1.5 M for the site R&D research portfolio. End budget cost savings totaled $500k by the conclusion of the project by prioritized spending.
SWAPNIL S. SATOOR
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LinkedIn Profile
Swapnil Satoor
Education
Penn State University
MBA Business Administration
Global Supply Chain Management (Dual MBA)
Western Michigan University
MS Manufacturing Engineering
University of Pune
First Class w/Distinction—Summa Cum Laude
BS Mechanical Engineering
Certifications
Certified Scrum Master
Digital Immersion at J&J,
Achiever of DRIVE
Lean Six Sigma Yellow Belt,
Green Belt (in process)
Kepner Trego—PMBOK
8D Methodology
5P Model of Lean Manufacturing
AAMI Process Validation
Proficiencies
cGMP
Confluence
Creo PTC
Design for Manufacturability (DFM)
Enterprise JIRA
EtQ
Excel
GxP
ISO 13485 & 16949
JIT
Microsoft PowerBI
Microsoft Project
Minitab
Monday.com
Mural
Planisware
SharePoint
Smartsheets
SolidWorks
Teams
Windchill
Volunteering
Mentoring
Habitat for Humanity
Lead Teambuilding events
Local soup kitchen
Memberships
Penn State Alumni
Society of Manufacturing Engineers
Contact Information
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LinkedIn Profile
Swapnil Satoor
Principal Project Manager Philips (Sonicare Consumer Div) 3/2018—2/2019
Collaborated to develop the innovation platform for new product launch Reduced the timelines by 6 months by onboarding suppliers earlier in the process by using DFMA and V model product development timeline Program Manager Johnson & Johnson 4/2015—3/2018
Engaged regional experts and prepared unified timelines for product launches, resulting in a cost savings and increase in on time reporting by 50%.
Reduced the forecasted project budget by 20% through effective budget management and resource hiring engagement.
Negotiated with business partner utilizing the decision-making process and influenced the outcomes of 3D printing to achieve a 30% reduction in the projected timeline.
Implemented test protocols for product design, controls, consumer product testing in order to increase on-time reporting by 80%. Program Manager IMDS (Contract Manufacturer) 6/2014—2/2015
Achieved 100% quality and delivery on customer supplier scorecards.
Defined and managed delivery goals for $3M product launch. Completed 1 month ahead of schedule with a final cost savings of $500k.
Coordinated cross-functional meetings with product development and application engineers.
Project Leader Zimmer, Inc. 10/2010—5/2014
Determined a budget of $1M, compiled expense projections & reconciled actual expenses to projections. Reached $500k savings at end of project.
Decreased standard costs by 30% through process layout optimization of machine and cleaning systems selections.
Reduced overall project timeline by 50% after implementation of a parallel process development.
Designed and executed process validations based on Six Sigma Methodology.
Scrap cost reduction of 30% by using pareto analysis on the Persona knee implants.
SWAPNIL S. SATOOR
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