current industry practices. Responsible for IQ/OQ and PQ phases. Coordinate projects directly with vendors and service providers to ensure that all validation and installation requirements are being satisfied during the execution of protocols. Develop timelines for all projects and ensure that deadlines and goals are being met.
Frequently update management and team on progress. Proactively work with members of the division or project team to identify issues that might delay the project; make recommendations to improve timelines for project completion. Compile and analyze validation data, prepare reports, and make recommendations for changes and/or improvements. Maintain all the documentation
pertaining to qualification and validation of assigned projects and equipment/systems. This position has no direct reports and does not supervise the work of any other employees.
Minimum requirements: Bachelor's degree or higher in Biology, Chemistry, Engineering (any field), or any related field of study, plus at least one (1) year of experience in the job offered or in any related position(s) in which the required experience was gained. Qualified applicants must also have demonstrable proficiency, skill, experience, or knowledge with the following: 1. Demonstrated validation experience in a c GMP environment. 2. Demonstrated experience with validations of USP water, controlled environments,
or equipment validations in a regulated environment. 3.
Demonstrated experience with validation documentation and related change control. 4. Demonstrated validation experience in a medical or medical device manufacturing environment. 5. Demonstrated experience with Biological NDA (New Drug Application) and ANDA (Abbreviated New Drug Application) products. No travel required. Work from home (WFH) benefit available. Additional Information: Job Site: 700 W. North Shore Drive, Hartland, WI 53029 Applicants may apply through the Company Website Link below. No calls or emails. EOE. Must be legally authorized to work in the United States without sponsorship. #LI-DNI
the Harley-Davidson experience. To keep building our legend and leading our industry through innovation, evolution, and emotion we need the best and brightest talent. We stand for the timeless pursuit of adventure. Freedom for the soul. Are you ready to join us?
Our Powertrain Operations facility, located on Pilgrim Road in Menomonee Falls, WI, is where the “jewel” of the motorcycle comes to life. Pilgrim Road employees produce engines and transmissions for the final assembly plant in York, Pennsylvania, as well as transmissions, and replacement parts for sale through Harley-Davidson® Genuine Motor Parts and Accessories business. Join our team as a Engineer Manufacturing and help build
the world’s most sought-after motorcycles. Job Summary Enhance assembly manufacturing by assuring that the process tooling, documentation, and equipment is set up for optimum safety, quality, delivery, and cost requirements.
Provide technical support to analyze and develop manufacturing control systems. Interface with Advanced Manufacturing, Quality, Product Engineering, Process Engineering, and Operations to ensure successful New Product Launch events and drive day to day improvements for current production. Develop LEAN initiatives to drive manufacturing efficiency improvements for safety, quality, delivery, and cost. Job Responsibilities Provide instruction, guidance and training in
the development of new processes and in the resolution of manufacturing problems Participate with product engineering to design parts for manufacturability Provide productivity improvements to reduce total manufacturing cycle time Reduce overall costs through tooling and process improvements Provide robust processes, tools and gages to reduce variation in the manufacturing process.
Provide processes that meet Harley-Davidson's standards in quality, ergonomics and safety along with sustaining required production rates Support the development and implementation of systems and processes to ensure continuous improvement, world-class-level quality, and a high performance work environment Interface with supervisors, process leads, product engineers and operators in the development of tools, fixtures, and machines to support existing and new product and process design Education Requirements Bachelor's Degree Preferred Experience Requirements Required Typically requires a minimum of 3 years of related experience.
Preferred Bachelor's Degree in Mechanical/Manufacturing Engineering Preferred Demonstrated understanding and practical application of lean manufacturing techniques. Detail process planning including work balancing, work standard development, operator and equipment utilization, ergonomics, PFMEA, quality controls, tooling, fixturing, and gaging.
Knowledge of process control and quality assurance, SPC, and process capability, documentation/information using CAD, Network/software and PC applications. Knowledge of ISO 9000 standards and their relationship to company policies, procedures and instructions. Experience with formal problem solving methodology. Demonstrated project management skills. Knowledge of PLC programming and troubleshooting capability. Harley-Davidson is an equal opportunity employer that continues to build a culture of inclusion, belonging and equity through our commitment to attracting and retaining diverse talent from all backgrounds, without regard to race, color, religion, interaction, interactionual orientation, national origin, gender identity, age, disability, veteran status or any other characteristic protected by law.
We believe in fairness and providing a level playing field for all. We foster a culture that thrives on diverse perspectives and contributions to ignite the creativity and innovation to fuel our business and enhance the employee and customer experience. The pay range shown represents the national average pay range for this role.
Your pay may be more or less than the stated range and is dependent on your geographic location and level of experience. We offer an inclusive compensation package for all full-time salaried employees including, but not limited to, annual bonus programs, health insurance benefits, a 401k program, onsite fitness centers and employee stores, employee discounts on products and accessories, and more. We welcome everybody to join our family and be united no matter who you are or where you come from. Learn more about Harley-Davidson here. Applicants must be currently authorized to work in the United States.
Direct Reports: No Travel Required: 0 - 10% Pay Range: 80,000 to 92,000 Visa Sponsorship: This position is not eligible for visa sponsorship Relocation: This position is not eligible for relocation assistance
Engineering jobs encompass a broad range of careers focused on designing, developing, and maintaining structures, systems, and devices. They are characterized by a strong foundation in mathematics, physics, and technology. Engineers often specialize in fields such as civil, mechanical, electrical, or software, striving for innovation and problem-solving. These roles typically require critical thinking, collaboration, and a relentless pursuit of efficiency and functionality. Engineering careers are instrumental in shaping the future, as they constantly push the boundaries of what's possible in construction, manufacturing, communications, and various other sectors.
Engineering jobs encompass a broad range of careers focused on designing, developing, and maintaining structures, systems, and devices. They are characterized by a strong foundation in mathematics, physics, and technology. Engineers often specialize in fields such as civil, mechanical, electrical, or software, striving for innovation and problem-solving. These roles typically require critical thinking, collaboration, and a relentless pursuit of efficiency and functionality. Engineering careers are instrumental in shaping the future, as they constantly push the boundaries of what's possible in construction, manufacturing, communications, and various other sectors.
Engineering jobs encompass a broad range of careers focused on designing, developing, and maintaining structures, systems, and devices. They are characterized by a strong foundation in mathematics, physics, and technology. Engineers often specialize in fields such as civil, mechanical, electrical, or software, striving for innovation and problem-solving. These roles typically require critical thinking, collaboration, and a relentless pursuit of efficiency and functionality. Engineering careers are instrumental in shaping the future, as they constantly push the boundaries of what's possible in construction, manufacturing, communications, and various other sectors.
