דרושים United States, Pennsylvania, Production Support ב-United States

• Overall ownership and accountability for developing, leading and driving new business development for DDD OU product platforms for identified strategic accounts to achieve revenue growth targets for commercial and product development sales.
• Advance the vision for strategic partnerships and customer opportunities as the SME for device services offerings, for all direct assigned accounts and regions. Establish business development programs including early adopter customers, target service levels, and CDAs (Customer Development Agreements).
• Responsible for driving the prospecting and lead development, monitoring sales and funnel performance. Lead and support customer facing teams in key customer interactions/strategic partnerships throughout the selling journey including critical customer/strategic collaboration, presentations, post-sales leadership and problem solving to deliver on revenue and growth targets.

• Bachelor's in Engineering, Science or Business-related discipline

• Minimum 15 years of experience in B2B, Combination Products, Business Development, Product/Program Management.
• Indepth knowledge and experience in pharmaceutical/medical device technical development, sales, marketing or related business.
• Experience in successfully leading global multi-functional or cross-functional teams, in developing cohesive relationships and producing strong business results.
• Excellent communication/negotiation/influencing skills and strong customer focus.
• Excellent commercial and financial acumen.
• Self-starter, highly motivated and ability to work independently with little or no daily supervision.

• MBA or master’s degree preferred
• Background with a good technical understanding and knowledge of Combination products, medical device qualification, primary packaging, Regulatory requirements and Program Management.
• Significant leadership team experience and executive leadership exposure.

• • Supervise shift personnel in the manufacture of customer products consistent with high safety and quality standards.
  • Troubleshoot problems arising on the shop floor as it relates to Advanced Manufacturing operations / products, in conjunction with quality standards for throughput and yields with the appropriate engineering support from Engineering functions within the value stream.
  • Maintain close observation of orders to keep informed of manufacturing status and, when needed, initiate the necessary steps to conform to schedule / staffing requirements.
  • Promote and support site initiatives including safety programs, lean initiatives, training programs, and consistently interpret & apply all policies, practices and procedures among plant team members.
  • Recommend and implement measures to motivate team members and to encourage employees to recommend ways to improve process, quality, safety and efficiency.
  • Routinely evaluate team member performance and identify training needs. Coach and counsel team members for performance, attendance and behavior. Participate in the resolution of team members relations issues.
  • Review and approve work time in the appropriate timekeeping system. Maintain and verify accuracy of the hours each team member has worked.
  • Adjust direct labor to support demand and manage available resources to ensure on time production and delivery of customer orders with consistent focus on labor absorption.
  • Ensure Safety regulations, OSHA, SOPs, and cGMP are followed.
  • Perform routine visual inspection of work areas for unusual occurrences, safety hazards, housekeeping, work space organization and generate work orders where appropriate.
  • Network with internal and external customers and other departments as appropriate.
  • Actively participate in site wide Safety Committee Team / projects.
  • Conforms with and abides by all laws, regulations, safety rules, policies, and work procedures, and all instructions.
  • Participate in special project teams as assigned.

• Education: Bachelor's in a technical discipline to include Business, Operations or Engineering preferred

• 5-8 years of experience in a manufacturing environment, including supervisory experience

• Working knowledge of repetitive process, high tech, manufacturing – mechanical automated systems.
• Must possess strong leadership and managerial skills
• General knowledge of OSHA/EPA/safety regulations, manufacturing and process automation
• Working knowledge of business and shop floor systems to effectively manage operations; prefer SPA and MS Office applications.
• Experience working with ISO9000, FDA and cGMP required.
• Ability to speak effectively before groups and employees in the organization.
• Understanding and experience in use of Lean manufacturing principles to be able to support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.

• Health Services\First Aid Certification Upon Hire preferred or
• Health Services\CPR - Cardiac Pulmonary Resuscitation Upon Hire preferred

• Self-motivated and solution-oriented personality.
• Excellent written and verbal skills.
• Good communication, project management, and interpersonal skills.
• Good organizational skills.
• Effective problem-solving skills.
• Must wear safety toe shoes, safety goggles, and hearing protection, as required, in production areas.
• Must follow and comply with Plant’s Dress and Hygiene Code (SOI).
• Must follow and comply with all Company and Plant policies, procedure (SOIs), rules and State and Federal laws

• Under the supervision of a trainer or supervisor perform the following duties...
• process trimmed product through washing and drying process per site SOI’s and work instructions.
• Ensure that the equipment is set up accurately.
• Ensure continual flow of product through the module from the mold press thru the trim press.
• Operate a mold press to produce molded panels of product following site SOI’s and work instructions.
• Operate a manual / automatic trim press as needed following site SOI’s and work instructions.
• Process product through any required special treatments such as sort, silicone, chlorination, etc.
• As needed, set up pack scales for weighing and packing of finished product and prepare carton labels for boxing and shipping.
• Alert the Area Supervisor to conditions that may prevent meeting production and quality expectations.
• Accurately maintain all required documentation and paperwork to ensure product traceability.
• Inspect molded/trimmed work to ensure quality product is being produced.
• Move materials into and out of the area as required.
• Properly clean and prep assigned workstations/equipment during and prior to the next available shift.
• Promotes and supports a Lean environment.
• Conforms with and abides by all corporate and site-specific regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance.

• High School Diploma or GED required

• 1-3 years manufacturing experience preferred

• Must possess an acute attention to detail
• Basic computer skills, i.e. use a mouse/keyboard.
• Ability to apply Good Manufacturing Practices (GMP)
• General use of computer work station and ability to use SAP commands is preferred
• Must be willing and able to work as a team member and make general decisions within authorized job responsibilities
• Must be able to train and guide others as required.
• Must be able to read and write in English

Management and implementation of facility projects and support in holistic building management. Perform a wide variety of mechanical, as well as pneumatic maintenance activities and some basic electrical activities on various pieces of equipment to maintain safe operations of equipment while maintaining production goals and quality standards. Other responsibilities include sourcing parts for obsolete parts and ordering them, documenting all the maintenance activities performed, PM's, installation, and validations of equipment. Will support and help other groups like Process Engineering, QA, and Facilities in resolving problems, improvements, investigations etc. In this role you will service/maintain several machines, while learning the others in the department. Work from prints, sketches, sample parts, verbal or written instructions. Interpret drawings, select material plan, and layout work in proper operational sequence. Maintain and setup vision systems during production.

• Identify problems by reading schematics/prints, where available, and make necessary repairs on the equipment or system to ensure safe operation of the machine or system.
• Respond to production maintenance request and any unscheduled down time.
• Troubleshoot and adjust or repair ancillary equipment like blow overs, bulb pullers, and heaters.
• Changeovers and setups on Vision Systems, make minor adjustments as required.
• Perform ink mixing as well as disposing of procedure as per set Safety/QS guidelines for printing machines.
• Perform necessary oil changes on machine gear boxes and dispose of used oil per established procedure.
• Rebuild/retrofit machine or machine components as per specifications.
• Perform installation, replacement or decommissioning of equipment.
• Perform validations as necessary for equipment.
• Work with training department to train new mechanics on machine repair, setup and related plant procedures.
• Complete PM's on or before the due date and communicate to proper authority of job completion.
• Source obsolete parts for equipment and make them stock item.
• Identify and locate parts in the stock room through MP2 or other such system.
• Participate in various company run programs like Continuous Improvement, Safety initiatives, audits, investigations etc.
• Support projects and improvement initiatives from engineering, process, QA, Safety and Operations groups.
• Document performed tasks for the day into the maintenance log before the end of each shift.
• Safeguard all corporate or plant confidential information.
• Use good housekeeping practices to maintain safe, (safe is always first) clean, orderly work area.
• Upgrade technical skills by various educational workshops, on-site or off-site trainings supported by WEST.
• Follow engineering department guidelines and procedures.
• Conforms with and abides by all safety rules, regulations, policies, work procedures and all instructions.
• Exhibits regular, reliable, punctual and predictable attendance.
• Implementation and collaboration of facility projects

• High School Diploma Or GED required

• 3 years manufacturing maintenance experience

• Experience with plastic injection molding preferred.
• Experience with robots and pick in place robots.
• Experience with ISO 9000 standards and GMP’s.
• Excellent communication and interpersonal skills.
• Experience with SAP or similar software for maintenance tracking.
• Agile working style.
• Ability to work weekends and overtime as required