דרושים United States, Williamsport

• • 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.

• Bachelor's Degree technical or business-related field required

• Minimum 5 years in a manufacturing environment required and

• • 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

In this role, you will be responsible for the production of components that meet or exceed pre-determined specifications. Responsible for inspection, packaging, labelling and completion of documentation necessary to provide quality, production and traceability records in accordance with Quality Systems ISO 9001/ ISO 13485.

• Ensures the quality of the parts produced by inspecting parts visually, ensures relevant documentation is recorded and signed off in real time.
• Maintaining accuracy of batch documentation at all times and ensuring that it is filled in and right first time.
• Completing measurements as required by the work instructions, reviewing measurement results and alerting appropriate personnel of any deviations from the customer specification or part print.
• Packages the parts according to customer specification and indicates the status of the part (accept/reject) according to proper procedure and specifications.
• Places finished product in correct location.
• Understands and safely operates all equipment.
• Reports and/or corrects unsafe working conditions.
• Performs secondary operations as necessary to meet customer specifications.
• Performs general cleaning of machines and ancillary equipment.
• Verifies the labels for correct part and lot numbers.
• Maintains proper level of packaging supplies at each machine.
• Maintains work areas in a clean and orderly manner by practicing good housekeeping.
• Define machine status on OEE System in order to determine machine downtime and run time.
• Compliance to all site Environmental, Health and Safety requirements, training and regulations.
• Compliance to all local site company policies, procedures and corporate policies.
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Act in accordance with the company’s guiding principles and adherence to the corporate Code of Conduct.
• Performs additional duties at the request of the direct supervisor.
• Maintains methods/procedures and all supporting documentation to meet the requirements of Quality Systems ISO 13485:2016.

• High School Diploma or GED required

• Previous production work experience would be an advantage.
• Knowledge of Good Manufacturing Practices (GMP) requirements would be an advantage.

• Must have good verbal reasoning, numerate ability and mechanical aptitude skills.
• Must have good communication skills, both written and oral.
• Must have good organizational skills.
• Must be able to work in a team environment.
• Basic knowledge and understanding of a computer.
• Must be willing to work in a controlled environment, which involves the wearing of a gown, cap and relevant personal protective equipment.

In this role, you will be responsible for the production of components that meet or exceed pre-determined specifications. Responsible for inspection, packaging, labelling and completion of documentation necessary to provide quality, production and traceability records in accordance with Quality Systems ISO 9001/ ISO 13485.

• Ensures the quality of the parts produced by inspecting parts visually, ensures relevant documentation is recorded and signed off in real time.
• Maintaining accuracy of batch documentation at all times and ensuring that it is filled in and right first time.
• Completing measurements as required by the work instructions, reviewing measurement results and alerting appropriate personnel of any deviations from the customer specification or part print.
• Packages the parts according to customer specification and indicates the status of the part (accept/reject) according to proper procedure and specifications.
• Places finished product in correct location.
• Understands and safely operates all equipment.
• Reports and/or corrects unsafe working conditions.
• Performs secondary operations as necessary to meet customer specifications.
• Performs general cleaning of machines and ancillary equipment.
• Verifies the labels for correct part and lot numbers.
• Maintains proper level of packaging supplies at each machine.
• Maintains work areas in a clean and orderly manner by practicing good housekeeping.
• Define machine status on OEE System in order to determine machine downtime and run time.
• Compliance to all site Environmental, Health and Safety requirements, training and regulations.
• Compliance to all local site company policies, procedures and corporate policies.
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Act in accordance with the company’s guiding principles and adherence to the corporate Code of Conduct.
• Performs additional duties at the request of the direct supervisor.
• Maintains methods/procedures and all supporting documentation to meet the requirements of Quality Systems ISO 13485:2016.

• High School Diploma or GED required

• Previous production work experience would be an advantage.
• Knowledge of Good Manufacturing Practices (GMP) requirements would be an advantage.

• 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

In this role, you will control flow of products and materials to and from manufacturing areas. Ship, receive, label, and properly store products and materials. Load and unload trucks. Operate industrial forklifts in a safe and professional manner. Transport supplies, tooling and equipment as required. Maintain high accuracy level on paperwork and electronic transactions / records.

• • Production Supply and Warehousing
    • Supply manufacturing areas with pallets, components, bags, boxes, lining material, and other materials as requested.
    • Ensure timely and neat stock placement so products remain damage-free.
    • Rotate stock to maintain FEFO (first expired, first out) and/or FIFO (first in, first out).
    • Maintain work areas following 6S guidelines and complete required cleaning tasks.
    • Execute cycle counts to maintain accurate stock levels.
  • Shipping and Receiving
    • Pull, label, and/or band, wrap, or otherwise prepare product for shipment to 3PL or for customer shipments.
    • Load product, materials, or equipment on freight carriers.
    • Unload inbound materials, equipment, and supplies.
    • Verify accuracy of paperwork, label, and put away materials in warehouse bins.
    • Follow all applicable procedures if damage is discovered during loading or unloading.
  • Utility
    • Assemble and supply cardboard totes to the production floor.
    • Assemble and supply scrap totes to manufacturing areas. Collect and process scrap for trash or recycle as needed.
    • Remove trash from production floor and empty dumpsters in the trash compactor.
    • Remove scrapped cardboard from production floor, load and empty cardboard compactor.
    • Load the scrap trailer(s).
    • Perform necessary paperwork and electronic transactions / records applicable to actions performed. Maintain high level of accuracy
    • Other duties as assigned.

• High School Diploma or equivalent preferred

• Minimum 6 months to 1 year of experience in a fast paced manufacturing environment.

• A learning Mindset
• Good attention to detail
• Good communication skills

• Assist in making necessary repairs and adjustments to machines and systems to ensure highest possible quality while maintaining lowest reject rate possible.
• Follow engineering department guidelines and procedures.
• Assist in performing changeovers and setups on systems and make minor adjustments as necessary.
• Have an understanding operation and set up and be able to maintain repair and a variety of machinery with the assistance of a trainer.
• Learn and perform preventative maintenance as required on schedule.
• Complete necessary production records and requisitions for materials and supplies.
• Interface with lead and purchasing/receiving coordinator with spare parts and material concerns.
• Support process improvement efforts and perform related duties.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and safety rules.
• Analyzes and resolves work problems and assists workers in solving work problems.
• Participate in validation activities as needed.
• Must observe good housekeeping practices.
• Participate in validation activities as needed.
• Exhibits regular, reliable, punctual and predictable attendance.
• Performs other duties as required and/or assigned.

• High School Diploma or GED required

• Minimum 3 years of experience in operating drill press, band saws, hand tools and grinding/abrasive tools with a mechanical / electrical background required. Vocational program / Trade School training may be substituted for experience.

• Ability to read mechanical diagrams and schematics.

Schedule-12 hour night shift 5:45p-6am

In this role, you will perform a variety of tasks and conducts test procedures in regard to the quality process, ensuring that the pre-determined high standards of quality are achieved and maintained.

• Review and approval of metrology reports, where appropriate, for batch release and validation purposes
• New product validation, analysis and reporting.
• Quality support to Engineering and Production Departments.
• Establish and maintain documentation in line with West Williamsport and West Pharmaceutical Services Quality Systems.
• Liaise with customers and suppliers on new and existing projects.
• Receiving and inspection of incoming goods and materials.
• Ensure that all parts/ materials, which require incoming inspection, conform to all requirements and applicable drawings and specifications.
• Maintain good communications both internally and externally.
• Ensures that all metrology equipment is correctly calibrated.
• Assists shift personnel with quality issues and/or measurement techniques.
• Assists in problem resolution with customers.
• Perform periodic audits as requested and completes necessary documentation.
• Archives quality records, samples and log procedures.
• Makes periodic clean-out of records and samples exceeding minimum retention requirements as per West procedures.
• Batch paperwork review and final decision to release product for shipment.

• Provide a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Maintain a clean, orderly, and safe workstation and environment at all times.
• Conform with and abide by all regulations, policies, work procedures, instruction, and safety rules.
• Exhibit regular, reliable, and punctual attendance.
• Perform other duties as assigned based on business needs.
• Keep current with new GMP compliance guidance and internal QA procedures
• Support new GMP compliance guidance and Data Integrity initiatives

• High School Diploma or GED Required.
• Preferred Associates degree in Metrology or QA; or 3 years’ on the job experience in a plastics manufacturing environment

• 3 years of job-related experience; in QA/QC and the use of measuring equipment.

• Able to be aware of all relevant standard operating procedures as per Company policy
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Possess ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude
• Willingness to learn new and review new analytical techniques
• Meet individual and departmental goals as required

• Ability to learn, understand, and remember normal tasks.
• Ability to hear, speak, and understand conversation in English in a normal tone of voice.
• Must maintain the ability to work well with others in a variety of situations.
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Read and interpret data, information and documents
• Work under deadlines with constant interruptions

• Champion a culture of health and safety in accordance with the highest standards of regulatory compliance.
• End to end ownership for the full business value stream.
• Build and maintain an excellent working relationship with the customer in the successful delivery of all client related projects (on time, within budget and in accordance with customer requirements/specifications).
• Support the Customer Account Manager in developing and executing a compelling strategic sales / business plan for the continued growth of the Value Stream
• Commercial leadership and management of Value Stream customers, including full operational P&L responsibility.
• Lead and drive the highest standards in Operational performance, 6S, people development to build on the culture of continuous improvement and growth, to deliver tangibly high quality performance outcomes
• Drive excellent cross functional relationships both within the Value Stream and companywide.
• Demonstrate excellent leadership visibility to drive engagement levels across the organisation.
• Development of the team to support Value Stream and performance and growth, including the recruitment, identification, development and retention of talent in the Value Stream.
• Strong coaching / development of team using development and retention plans as appropriate.
• Other duties assigned.

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

• Experience: 8-10 years of experience in leading and managing a diverse team in a fast paced and highly regulated environment.
• 3+ years’ experience of working in medical devices sector or similar is an advantage.
• Ideally have injection molding and tooling knowledge / expertise.

• General knowledge of OSHA/EPA/safety regulations, manufacturing and process automation.
• Working knowledge of business and shop floor systems to effectively manage operations; prefer SAP and MS Office applications.
• Experience working with ISO9000, FDA and cGMP required.
• Ability to read and interpret documents and drawings, specifications, safety rules, operating instructions, procedure manuals and regulatory documentation.
• Ability to write routine reports, correspondence and process documents.
• Ability to speak effectively before groups and employees in the organization.
• Write monthly progress reports and capital request.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this job description.
• 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.

• Medical Device manufacturing requires strict adherence to standards. Working environment is a manufacturing facility, which houses plastic injection molding machines. Must tolerate fumes and particulate generated from various plastics. Work areas are equipped with adequate lighting, cooling/heating and equipment that are in a good working condition. Must work constructively in an environment that may be stressful due to competing resources while at all times maintaining company confidentiality.
• May stand or sit for extended periods of time. Must transport oneself to and from other areas of the facility and travel to other divisions when necessary. Must have good visual acuity. If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues. Hearing ability should be sufficient to hear audible alarms from distances up to 150ft.
• The ability to be able to lift and carry various items up to 50lbs.
• Minimal travel