דרושים ב-West Pharma ב-United States

• Perform sampling, inspections, and testing of in-process and finished goods products per applicable procedures and AQL plans, utilizing both visual means as well as calibrated test equipment to include laser micrometer, optical comparator and other equipment as applicable
• Release acceptable in-process and finished goods product for further processing and/or shipping as applicable per site
• Understand and follow applicable ISO standards requirements
• Perform review of inspection records to assure product conforms to specifications and proper documentation practices
• Retains sample of finished products and maintains all applicable documents to form batch records and ensures appropriate batch records disposition (i.e. filing, scanning etc.) as necessary
• Print documents from Master Control, shopfloor or other software program and manages documents related to the Quality System
• Segregate nonconforming product and handle quarantined product and raw materials as applicable by site
• Generate rejection and deviation reports as directed by site
• Perform trace back investigation of nonconforming raw material and product as directed by site
• 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
• Other duties as assigned

• High School Diploma or GED Required

• Minimum one year manufacturing experience required

• Must poses an acute attention to detail
• Basic computer skills

• 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.
• Performs other duties as assigned based on business needs.

• High School Diploma or GED Required

• No min required

• 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

The Controls Technician is responsible for maintaining, troubleshooting, and continuous improvement on electrical and automated control systems within our medical device manufacturing facility. This role ensures that all production equipment functions efficiently and safely, complying with industry standards and regulations.

• Diagnose and resolve issues with automated assembly equipment, including PLCs, HMIs, robots, vision systems, sensors, and other control devices. Assist the assembly maintenance team with resolving electrical and controls related issues and helping to resolve escalated equipment issues.
• Perform regular maintenance on electrical and control systems to ensure continuous production operations.
• Collaborate with engineering and production teams to identify opportunities for process and system improvements. Contribute to continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste within the production environment.
• Assist with the installation and commissioning of new control systems and equipment upgrades.
• Maintain accurate records of system layouts, wiring diagrams, and maintenance logs.
• Ensure all control systems comply with relevant medical device manufacturing regulations and quality standards, such as ISO 13485 and FDA guidelines.
• Adhere to all safety and environmental policies and standards in the execution of work duties.
• Other duties as assigned.

• Strong analytical and troubleshooting skills.

• Excellent verbal and written communication skills.

• Ability to work collaboratively in a fast-paced, cross-functional team environment.

• Associate degree in Electrical Engineering, Industrial Automation, or a related field.

• 3+ years of experience in a controls technician role within a manufacturing environment, preferably in the medical device sector.
• Proficiency with PLC programming (e.g., Allen-Bradley, Siemens), HMI development, Vision programming (e.g., Cognex, Keyence), Robots (e.g., Fanuc, ABB), and SCADA systems.
• Familiarity with GMP, ISO 13485, and FDA regulations in medical device manufacturing.

• Experience in automation equipment used in medical device industry or other regulated industry.
• Knowledge of quality systems requirements, FDA Quality System Regulation, cGMP and ISO 9002.

• Must be able to work a 40-hour work week, plus overtime and/or irregular hours as required to complete assignments. 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 and distinguish color differences for product and safety issues.
• Medical Device manufacturing requires strict adherence to standards. Working environment is a clean room manufacturing facility, which houses plastic injection molding machines. Must work constructively in an environment that may be stressful due to competing resources while at all times maintaining company confidentiality.

Lead and manage Technology Transfers, that requires extended knowledge and relevant experience, referring to West sites and process capabilities, for the Global Sites as assigned to the timelines and objectives established. Independent work to ensure that all transfer risks are assessed and appropriate mitigation actions defined by TT team and West network experts. Enhancement of Transfer documentation templates and training of NetOp and site resources. Contribute to the TT team success managed by other leads.

• Propose and agree with NetOp QA TT execution strategy and TT scenario
• Works independently to manage technology transfer projects, globally, to the timelines and objectives established:
• TT projects high complexity, within a region
• Low and mid complexity TT projects between regions
• Manage each project encompassing all aspects of the transfer project (quality, items, customers, capacity, product strategy, transport, equipment, regulatory...)
• Work with Global QA NetOp to determine TT strategy and acceptance criteria.
• Lead and execute transfer projects using West Project Management Best Practices.
• Compiling and approval of a Project Charter, opening and closing of a Change Control
• Planning – priority, complexity, schedule, duration, required resources
• Execution – coordinate completion of all TT activities, documentation, production and testing of required batches
• Communication within West and with customers
• Active contribution in the transfer projects, as a member of a TT core team, managed by other transfer Project Managers
• Gathering and analyses of numerous required data (operation, manufacturing, quality) and information for TT Requirements plan.
• Independent preparation and completion of the Technology Transfer Risk Assessment and Risk Mitigation Plan
• Compiling and analyses of test results and providing appropriate recommendations
• Establish the operational parameters, CQA’s and acceptance criteria to be evaluated
• Guide the West resources on managing required PNR and deviation investigation
• Compiling, review and approval of Technology Transfer Equivalence Protocol (document defining documentation, references, test procedures and acceptance criteria
• Compiling, review and approval Technology Transfer Equivalence Protocol Summary Report and Customer Summary Report
• Manage review and approval of TT documents on time
• Compiling and approval of Technology Transfer Gap Assessment if required
• Ensure West global tooling experts do assessment of tools conditions and gain for their recommendation about which tools will be used for production of the TT batches.
• Manage knowledge transfer between a sending and receiving site.
• Takes a new perspective using existing solutions to recommend and apply continues improvement and optimization of transfer processes and documentation templates
• Training of less experienced NetOp colleagues

• Minimum: Master’s in Engineering or Applied Sciences

• Strong analytical, communication, and interpersonal skills.
• Robust West Pharmaceutical product / process knowledge incl. Master Control & West Quality Systems.
• Lean Six Sigma Green Belt & Minitab software
• Strong extended project management skills with the ability to deploy solutions in a global environment.
• Influence - ability to influence effectively across multiple functions and regions
• Driving execution - through determining action steps and milestones required to implement a specific business initiative; adjusts activities or timelines as circumstances warrant.
• Customer oriented mindset

• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• According to the principles of health and safety at work (substantiated by the Safety Leadership Statement), the job holder is aware of his/her particular responsibility regarding work safety and acts accordingly at all times
• Able to comply with the company’s quality policy at all times.
• The job holder is aware of his/her special responsibility for quality according to the company’s quality policy and conducts his/her activities in accordance with the company quality policy at all times.
• The job holder respects all specifications arising from the cGMP requirements and from the specifications DIN ISO 15378 and DIN EN ISO 9001 as per its current state and also as it applies to any future amendments. Support and contribute in Lean Sigma programs and activities towards delivery of the set target.

• While performing the duties of this job, the employee is regularly required to, sit, stand, walk, talk, hear, see and use hands and finger to operate office equipment (ie phones, computers, copies, etc.).
• Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites.
• The ability to be able to lift and carry various items up to 40 pounds.
• The employee is occasionally exposed to wet and/or humid conditions and fumes or airborne particles.
• The employee occasionally works near moving mechanical parts and or equipment.
• The noise level in the office work environment is usually quiet. The noise level in the manufacturing work environment is moderate to loud. Hearing protection is required at all times in the manufacturing work environment.
• Job requires mental skill or ability such as communication, decision making (sometimes quick), interpreting data, reading or writing, organization, problem solving, understand direction, supervise and speak publicly, etc.

• • 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

The Controls Technician is responsible for maintaining, troubleshooting, and continuous improvement on electrical and automated control systems within our medical device manufacturing facility. This role ensures that all production equipment functions efficiently and safely, complying with industry standards and regulations.

• Diagnose and resolve issues with automated assembly equipment, including PLCs, HMIs, robots, vision systems, sensors, and other control devices. Assist the assembly maintenance team with resolving electrical and controls related issues and helping to resolve escalated equipment issues.
• Perform regular maintenance on electrical and control systems to ensure continuous production operations.
• Collaborate with engineering and production teams to identify opportunities for process and system improvements. Contribute to continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste within the production environment.
• Assist with the installation and commissioning of new control systems and equipment upgrades.
• Maintain accurate records of system layouts, wiring diagrams, and maintenance logs.
• Ensure all control systems comply with relevant medical device manufacturing regulations and quality standards, such as ISO 13485 and FDA guidelines.
• Adhere to all safety and environmental policies and standards in the execution of work duties.
• Other duties as assigned.

• Associate degree in Electrical Engineering, Industrial Automation, or a related field.

• 3+ years of experience in a controls technician role within a manufacturing environment, preferably in the medical device sector.
• Proficiency with PLC programming (e.g., Allen-Bradley, Siemens), HMI development, Vision programming (e.g., Cognex, Keyence), Robots (e.g., Fanuc, ABB), and SCADA systems.

• Familiarity with GMP, ISO 13485, and FDA regulations in medical device manufacturing.
• Strong analytical and troubleshooting skills.
• Excellent verbal and written communication skills.
• Ability to work collaboratively in a fast-paced, cross-functional team environment.

• Must be able to perform job duties as required with limited physical demands.

• Designing and implementing Business Intelligence (BI) solutions throughout the organization.
• Establishing and developing relationships with key internal stakeholders to understand the distinct BI needs across all business departments and support the service delivery.
• Building and preserving productive relationships with a broader business network, IT associates, and vendors, while addressing and resolving potential issues.
• Aiding in the creation of a uniform approach towards the execution of BI projects.
• Overseeing multiple BI projects, ensuring smooth progression from inception to completion.
• Offering maintenance services for existing BI solutions and serving as the primary escalation point for issues related to BI projects.
• Bridging the gap between business necessities and technical considerations, negotiating solutions, and encouraging creativity when feasible.
• Contributing to the ongoing growth and delivery of BI services, inclusive of projects, while ensuring constant protection and security of business data.
• Define and translate business rules and processes into S4 Hana data solutions
• Lead projects impacting data integration for manufacturing KPI’s
• Providing guidance, templates, reporting and instructions to Supply Chain, Operations, Quality, Warehousing and Finance regarding the required maintenance of Master Data and transactions.
  • E.g. Tier meeting dashboards, reports such as OEE, scrap, sales & absorption
• Supporting equipment interfacing needs.
  • E.g. Intouch & Edart MRP’s
• Supports and continuously improves procedures and processes related to but not limited SAP S4 Hana & Power Bi.
• Other duties as assigned.

• Bachelor's degree in computer science, business or related field; or equivalent work experience.

• Related SAP & Power BI Work Experience: Minimum 5 years of experience
• A minimum of 5 years’ experience in a Business Analyst role or a similar position with relevant experience.

• Experience in delivering or managing BI projects.
• Familiarity with high-volume manufacturing operations.
• Proven ability to manage multiple projects simultaneously, demonstrating excellent multitasking and prioritization skills.
• Proficiency in translating technical language into comprehensible terms.
• Experience in implementing, configuring, and testing BI solutions.
• Experience in developing within the Microsoft Power Platform environment, with a focus on Power BI, Power Automate, and Power Apps.
• Working knowledge of Microsoft Power BI Desktop, management of Microsoft Teams groups, OneDrive storage, and Microsoft SharePoint.
• Proficiency in using Microsoft 365 applications, with an understanding of its interconnections with Microsoft SharePoint and Microsoft Power Platform.
• Experience in data extraction, cleansing, and integration.
• Understanding of Lean Manufacturing principles, such as Value Stream Maps, Continuous Improvement, and Kaizen.
• Ability to accurately document work performed.
• Ability to work independently on own projects while working concurrently with all departments.
• Awareness of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.

• Manufacturing\Six Sigma Green Belt Certification within 1 Year required

• Self-motivated, results- and solution-oriented personality
• Very good organizational and project management skills
• Highly analytical and structured way of working
• Ability to successfully collaborate with teams across different countries and organizational levels
• Fluent in English
• Proficient in Microsoft based programs
• Ability to assert technical solutions and standards in an international environment
• Excellent communication skills and ability to collaborate well with people across different countries
• Manage working with colleagues in different time-zones
• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Position operates in a professional office environment. May stand or sit for extended periods of time
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of related activities
• Read and interpret data, information and documents
• 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
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems