Jacob Klemmer, Pmp Email & Phone Number

Philadelphia, PA, US

New Brunswick, New Jersey, US

Support wound closure product life cycle management and new product introduction efforts within the Global Technical Operations group

Kalamazoo, MI, US

• Lead engineer for Stryker's Orthopedic Knee Replacement manufacturing line
• Lead and execute capacity expansion projects through acquisition and validation of new automated inspection equipment (CMMs) and robotic equipment upgrades to increase production capacity by +50%
• Direct and implement Enterprise Change Requests (ECR) to maintain production output and insulate the process from equipment downtime and compliance risks
• Plan and execute process development, equipment qualifications, and validation strategies based on business needs and resource limitations
• Conduct process improvements and root cause analysis with cross-functional stakeholders

Rahway, New Jersey, US

• Support the design, construction, commissioning, and licensing of a new syringe filling facility for HPV and Pneumococcal Vaccines
• Technical & operational engineering process lead for a new-to-market Pneumococcal Vaccine formulation
• Support the design of equipment through Factory Acceptance Testing (FAT) & IQ/OQ activities per customer requirements
• Conduct studies to assess equipment prototypes and process parameters to reduce cycle times in support of tech transfer
• Design multi-platform systems to seamlessly integrate automation into new facility processes and simplify user experience
• Manage and direct the design and implementation of Single-use Product Contact Components (PCCs) for the entire facility

Rahway, New Jersey, US

• Supported the production line restart effort and PPQ completion for Vaxneuvance's Adjuvant Protein Bulk Intermediate
• Supervised, scheduled, and upskilled 15+ shopfloor personnel across two shifts to meet production demand
• Managed and approved employee timesheets across a three-shift production schedule
• Collaborated with equipment vendors & engineers to troubleshoot equipment, reduce downtime, and validate cleaning cycles
• Authored technical communications and protocols to drive procedural changes and reduce process deviations
• Led sitewide safety investigations and implemented system level CAPAs through the WP Safety Incident Investigation Team

Rahway, New Jersey, US

• Supported Merck's vaccine formulation, fill and packaging manufacturing operations through 24/7 shopfloor surveillance
• Investigated and closed 30+ Quality Notifications (QNs) and developed the QLO-LVV E2E Deviation Management Loan Labor Partnership by increasing QLO loan labor by 450% and expanding the LVV IPTs impacted by 400%
• Authored quality investigative reports for aseptic operational and procedural deviations through root cause analysis and internal document audits to remain compliant with FDA regulations
• Audited batch records and monitored aseptic process validations to ensure regulatory, GMP and ALCOA compliance
• Spearheaded sitewide regulatory inspection readiness initiatives such as a 25+ DeltaV alarm response SOP consolidation and a Sterile Supply FIFO and expiry improvement project
• Digitalized Sterile Supply batch records and GMP document workflow through internal shopfloor application database

New Brunswick, NJ, US

• Assisted Talent Acquisition and their efforts during career fairs to compile candidates for interviews
• Educated student organizations and incoming interns/co-ops on J&J’s culture and the importance of the Credo
• Created events to give students the opportunity to meet company representatives in an informal setting

Raritan, NJ, US

• Developed and coproduced an innovative packaging process to retain 38% of market shares due to recent BSI regulations
• Extracted and analyzed Proxisure suture cartridge data to justify a 60% reduction in lot sample size and cut costs by 65%
• Led Operation Smile for the Somerville campus by facilitating collaboration between 18 departments to raise $32,000+
• Coordinated with suppliers to implement a more robust fixture to maximize manufacturability for Stratafix Symmetric
• Organized design review documentation for franchise wide SKU consolidation from 15k to 8k global product codes
• Initiated and completed the revision of Material Specifications to align and convert product codes to meet CE regulations

Arlington, Texas, US

• Initiated and administered a $400,000 project allowing all amputees the ability to ride themed park attractions
• Assessed and enhanced 150+ rides in 13 parks and 3 different countries
• Coproduced a disability harness device that contributed a cost savings of $7,000 per unit
• Developed a product serial number ordering system that identifies and categorizes all harness straps for Six Flags parks
• Calculated the minimum headwind speeds and increased the threshold required for proper operation of a 4D Free Spin Ride
• Programmed a data acquisition device via an Arduino board that read 2 analog signals in order to produce a spring constant

Newark, Delaware, US

• Acquired 80 hours of clinical experience in the prosthetic and orthotic field
• Assisted 5 practitioners and oversaw 2 custom orthotic construction and adjustments
• Collaborated with technicians to fabricate a custom Ankle Foot Orthotic (AFO) and prosthetic leg
• Developed a key understanding of MASS position theory and Root Theory utilized in podiatry

• Immersed myself in and adapted to Chinese culture and various societal environments
• Exposed to international industry and engineering design such as the Ford China Operations Plant
• Studied the manufacturing and industrial processes of large Fortune 500 companies

University Park, PA, US

Water can be a scarce commodity in many regions of the world and populations are required to walk long distances to find viable drinking options. Cisterns have long been used as a method of harvesting rain water in order for people to have life’s basic necessity available in their backyard.I led a team that consisted of engineering students from Penn State.

Horsham, PA, US

• Adapted to and operated in high intensity, stressful environments during peak customer hours
• Established essential multitasking skills to ensure all food orders were prepared correctly and promptly

Bachelor Of Science (Bs), Mechanical And Biomedical Engineering

Education record

Master Of Business Administration - Mba