Value Stream Engineer - Miami, United States - Noven Pharmaceuticals

Description

Overview:

Responsible for the support of manufacturing processes, instrumentation and equipment from manufacturing values steam. Integral part of the value stream team accountable for delivery of improvements in the areas of safety, quality, service and cost per the team goals and metrics. Provides expertise in engineering, design, process and/or scale-up. Assists manufacturing operation in problem solving with regards to materials, components, equipment and systems. Develops and recommends new process solutions and technologies to achieve cost effectiveness and improved product quality. Recommends process improvements for the production of therapeutic products using tankage, piping, coating /oven systems, laminating dies, pouching machines, printing, bar code, vision and packaging systems.

Establishes operating equipment specifications and improves manufacturing techniques. Involved in new product scale-up, process optimization, technology transfer, design of experiments, as well as process validation activities. Interfaces with appropriate departments to ensure processes and designs are compatible for new product technology transfer and to establish future process and equipment automation technology. May lead process improvement team (s) consisting of production personnel and technicians.

• Applies knowledge of engineering principles and practices in broad areas of assignments and related fields.
• Makes decisions independently on engineering problems and methods, and represents the organization in meetings, collaborations, conferences to resolve important questions and to plan and coordinate work.
• Investigate equipment failures and difficulties to diagnose faulty operation, and to make recommendations to maintenance crew.
• Oversee installation, operation, maintenance, and repair to ensure that machines and equipment are installed and functioning according to specifications.
• Recommend design modifications to reduce machine downtime and material scrap rates.
• Designing and implementing cost-effective equipment modifications to help improve safety and reliability.
• Provides technical coverage and support for maintenance and repair of plant and infrastructure components and equipment.
• Provide hands on training to Maintenance staff and Mfg. LMOs on Equipment operation best practices.
• Responsible for recommending Value Improvement Projects (VIP) to meet the annual savings target.
• Develop, coordinate, and monitor manufacturing methods, fabrication, and operation of production Equipment/Processes. Consults with supervisor concerning unusual problems and developments.
• Practices company safety and quality policies and procedures. Actively adheres to and require conformance to the same.
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
• Ensure equipment related information such as trends, issues, availability, performance, and quality (OEE - Overall Equipment Efficiency) associated with machine maintenance, calibration and spare parts requirements is properly analyzed and then passed onto the production, maintenance and calibration organizations for problem solving and improvements.

Competencies:

• Works on assigned value stream with diverse scope where analysis of data requires an in-depth evaluation of various factors.
• Capable of handling multiple projects at once
• Must be able to work in a high achieving environment seeking standards of quality and compliance in line with our work processes and outcomes, while meeting regulatory requirements.
• Must be able to communicate engineering solutions clearly, accurately and tactfully to cross functional teams as well as with external contacts.
• Ability to work effectively with people, being helpful, respectful, approachable and team oriented, while building a strong work relationship and a positive work environment.
• Self-directed, takes ownership of work and follows through.
• Receptive to feedback, willing to learn and embraces continuous improvement.

Education & Experience:

BS or equivalent in Mechanical, Industrial, Electrical or a related engineering discipline with 3-5 years of experience and/or training; or equivalent combination of education and experience. Experience in the pharmaceutical or medical device industries will be an asset. Engineer must possess the basic understanding of engineering fundamentals, engineering best practices, troubleshooting methodology as well as familiarity of the scientific method. Experience with AutoCAD or SolidWorks a must.

Good written and oral English communication skills. Computer literate a must, strength with Statistics used for Design of Experiments as well as MS Project and Excel required. Knowledge of GMPs, Best Practices, best in class, ASTM E2500 Good Engineering Practices, OEE, Lean Six Sigma, Quality by Design techniques and approaches, Experience with Minitab and SolidWorks is a plus.

Work Environment:

Office, Utility Yard, Plant floor, Plant Floor Support Areas, Active pharmaceutical products.

Physical Demands:

The employee is occasionally required to climb or balance; stoop, kneel, crouch, or crawl; and smell. The employee must be able to sit or stand for several hours, as well as lift and/or move up to 100 pounds.