דרושים Tooling Process Improvement Engineer ב-West Pharma ב-United States, Saint Petersburg

• Service and installation of trim dies and mold presses to obtain optimal process condition and meeting of products quality requirements.
• Perform preventive maintenance of trim dies and compression molds to ensure the tooling’s are in good condition.
• Carry out first line troubleshooting of defective products and other technical issues timely and effectively to minimize the disruption to production and escalate as required.
• Dismantle tools (dies and molds) that due for servicing. (sharpening, cleaning).
• Assist in overhauling end of life dies with new rebuild kit.
• Ensure all necessary safety features are checked and tested according to the requirements before start operation / hand over process.
• Ensure proper shift handover by completion of document and records according to procedures and proper housekeeping of work areas in toolshop.
• Perform any other duties as assigned by superior.

• Must be skilled with lathe and mill work.
• Must have experince with surface grinding.
• Good mechanical aptitude needed. Proficiency with math and print reading necessary.

• High School Diploma or GED Required.
  • Tooling Degree or Trade School certificates preferred.

• Minimum of 3 years of machining experince required.
  • Experince with operating and programming CNC machines
  • Experince with Haas CNC a plus.

• 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
• Programming conversational CNC.
• Compression Mold repair experience
• Understanding of six-sigma and processing improvments
• Able to comply with the company's safety policy at all times
• Ability to use Excel and Word.

In this role you will debug, sharpen, and maintain Progressive, Compound stamping tools and assembly tools. Also make new and rebuild stamping tools.

• Troubleshoot manufacturing problems on dies.
• Sharpen and rework carbide and Steel components.
• Work with and advise Tool & Die Makers, Machinists and Mechanics on die issues.
• Manage component inventories.
• Manage tool Maintenance schedules.
• Utilize CNC: CMM, EDM and Mill to maintain Dies.
• Pull and set tooling as required for troubleshooting.
• Clean machines and tool room equipment.
• Hold dimensional tolerances called out on drawings.
• Read, Review and Revise prints.
• Other duties as assigned.
• Adhere to all company policies.
• Must observe all good housekeeping practices.
• Must be able to self-start/time manage and follow written or verbal instructions.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual, and predictable attendance .
• Safety glasses, hairnet, face/beard cover, gloves, slip resistant steel toed safety shoes and hearing protection as required.

• High School Diploma or GED Required.
  • Trade School preferred.

• Programming Conversational CNC.
• Programming Conversational CMM.
• Stamping experience High speed Approximately 400 SPM.
• Understanding of six-sigma and processing improvements.
• Able to be aware 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 environment background preferred
• Must be able to express and exchange ideas with employees
• Must be able to build strong relationships with direct reports and peers

• Must be able to travel up to 5% of the time

In this role, you will lead international and multifunctional teams to resolve the larger/complex/high risk issues. You will use standard problem solving methods to drive the investigation, find the Root Cause and define appropriate capa's in a structured and well documented manner while communicating clearly with all stakeholders.

• Lead multifunctional teams working on specific complex / high risk problems that are surpassing the expertise or availability from our Local/Global SME – and OPMO team members.
• Define the Problem scope, coordination needs and the method to assure resolution of the Root Cause of the problem, across West.
• Coordinate closely and liaise with local and global functional team members from Quality, Operations, Research and Development, Engineering, Supply Chain to ensure the project gets the full cooperation of the West Network.
• Assure the proper communication on status, progress and future actions to all stakeholders, including customers and Executive management at the level of Tier 5 and Tier 6.
• Use standard Problem Solving techniques such as LEAN, Six Sigma, A3, 8D, DMAIC…etc.
• Drive standardization and the use of best practices to optimize our production capabilities while resolving the issues.
• Define global Capa’s across multiple sites and business units.
• React with high sense of urgency and agility.
• Responsible for the performance and results of the team. Performs the day-to-day management of the assigned leadership team in compliance and consistent with the West values, policies, and procedures
• Provide a “Customer Service” attitude when interacting with internal and external customers
• Prepare reports as may be required on a routine basis or on demand within established deadlines
• Other duties as assigned

• Bachelor's Degree in Engineering or another scientific area or equivalent experience required
• Master's Degree in Engineering or another scientific area preferred

• Minimum 8 years in a similar position within the manufacturing industry required
• 3 years` experience in leading multifunctional teams of professionals globally required
• Good knowledge of LEAN and 6 sigma manufacturing principles (Green belt) required, black belt preferred.
• Good know-how and experience in Project management required
• Solid cGMP knowledge required

• Excellent communication skills (in English)
• Ability to assert technical solutions and standards in an international environment
• Ability to collaborate well with people across different countries
• Self-motivated, results- and solution-oriented personality
• Ability to work independently
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety and quality policies at all times

• 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

In this role, you will lead international and multifunctional teams to resolve the larger/complex/high risk issues. You will use standard problem solving methods to drive the investigation, find the Root Cause and define appropriate capa's in a structured and well documented manner while communicating clearly with all stakeholders.

• Lead multifunctional teams working on specific complex / high risk problems that are surpassing the expertise or availability from our Local/Global SME – and OPMO team members.
• Define the Problem scope, coordination needs and the method to assure resolution of the Root Cause of the problem, across West.
• Coordinate closely and liaise with local and global functional team members from Quality, Operations, Research and Development, Engineering, Supply Chain to ensure the project gets the full cooperation of the West Network.
• Assure the proper communication on status, progress and future actions to all stakeholders, including customers and Executive management at the level of Tier 5 and Tier 6.
• Use standard Problem Solving techniques such as LEAN, Six Sigma, A3, 8D, DMAIC…etc.
• Drive standardization and the use of best practices to optimize our production capabilities while resolving the issues.
• Define global Capa’s across multiple sites and business units.
• React with high sense of urgency and agility.
• Responsible for the performance and results of the team. Performs the day-to-day management of the assigned leadership team in compliance and consistent with the West values, policies, and procedures
• Provide a “Customer Service” attitude when interacting with internal and external customers
• Prepare reports as may be required on a routine basis or on demand within established deadlines
• Other duties as assigned

• Bachelor's Degree in Engineering or another scientific area or equivalent experience required
• Master's Degree in Engineering or another scientific area preferred

• Minimum 8 years in a similar position within the manufacturing industry required
• 3 years` experience in leading multifunctional teams of professionals globally required
• Good knowledge of LEAN and 6 sigma manufacturing principles (Green belt) required, black belt preferred.
• Good know-how and experience in Project management required
• Solid cGMP knowledge required

• Excellent communication skills (in English)
• Ability to assert technical solutions and standards in an international environment
• Ability to collaborate well with people across different countries
• Self-motivated, results- and solution-oriented personality
• Ability to work independently
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety and quality policies at all times

• 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

In this role, you will coordinate/assign work and provide operational support in your area of responsibility for the construction and/or repair of molds, dies, and/or ancillary equipment. Oversee the set-up, tooling, programming, and operation of CNC and/or manual milling, turning, and grinding machines that facilitate mold and die component manufacture/assembly. Schedule projects into suitable machines. Ensure inspection methodologies are appropriate, repeatable, and capable of maintaining specifications within tolerances. Assist in documenting new and existing procedures throughout the facility. Investigate, recommend and apply appropriate technology enhancements. May support in designing tools the manufacturing facilities require for production.

• Coordinate and assign work throughout the machine shop, including tooling construction, machine repairs/calibrations/maintenance in collaboration with the production planner and site manager. Provide operational support for team members and equipment.
• Conduct performance management and related activities of those employees within your area of responsibility in coordination with site manager.
• Ensure that all appropriate Quality Assurance procedures are followed. Accept responsibility for the quality of the work produced in the machine shop. May assume responsibility for various assigned projects to improve product quality and tooling designs.
• Troubleshoot & remediate problems with existing production tooling at this facility &/or outlying plants. May work with cross-functional teams throughout all West locations to develop best practice standards.
• Devise machining/assembly processes for tooling projects that minimize cycle time & maximizequality.
• Develop & document new process procedures (in current SOI format) in collaboration with manufacturing engineer and area SME’s. Assist in providing training for affected employees on the safe & effective use of those procedures.
• Assess, improve, & document existing processes (in current SOIformat).
• Develop specific objectives and manage work assignments with guidance to achieve personal objectives in conformance with overall business goals. Able to identify gaps in the department and fill them to support thedepartment.
• Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.

• Challenge processes, remain open to ideas and changes to continuously improve, seek better alternatives, and drive change.
• Lead Continuous Improvement teams & ensure timely completion of projects. Provide quality feedback to appropriate team members to support Continuous Improvement.
• Help and instruct fellow employees as needed & assist in the orientation & training of newemployees.
• Coordinate equipment maintenance per vendor/West maintenanceschedule.
• Document drawing changes (ECNs), inspection results, etc. as needed per West & cGMP requirements in collaboration with QA manager and manufacturing engineer.
• Collaborate with the global tooling team (TLCM, Design, Bodmin and German tool shops) on tooling and manufacturing issues. Collaborate with production plant stakeholders on repairs and tooling related issues.
• Observe all plant safety rules, regulations and HSE policies. Maintain compliance with all HSE policies and procedures for all team members.
• Keep equipment & working areas in a clean & orderlycondition.
• May maintain and support existing tooling and coordinate tooling orders for manufacturingplants.
• May implement innovative solutions to meet or exceed customer quality expectations. Maintain awareness of new technology trends, materials, and design/analytical software and able to design experimental molds, commercial molds, MTD´s and devices.
• May write engineering studies and technical reports to support tool designs andfeatures.
• Other duties asassigned.

• High School Diploma with 10-15 years related manufacturing (precision machining) experience required or
• Associate's Degree with 5-10 years related manufacturing experience (or equivalent education / training / experience); required or
• Bachelor's Degree with 5+ years manufacturing experience required

• Frequent standing, twisting, bending, reaching, pushing, pulling and walking.
• Must have excellent organizational interpersonal and problem-solving skills and be able to interface with employees in all levels of the organization and in a variety of situations.
• Effective personal time management skills and must be able to multi-task, work under time constraints, and prioritize with constant interuptions.
• Must have the cognitive ability to plan, execute to goal, supervise and coordinate the work of a team in area of responsibility.
• Ability to quickly adapt to changes in a dynamic environment.
• Must be able to maintain confidentiality and effectively resolve conflicts.
• 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.
• Leadership skills and 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.
• Read and interpret data, information and documents.
• Observe and interpret situations, analyze and solve problems.
• Ability to make independent and sound judgments with guidance from management as needed.

• Support Engineering and Tooling to update and approve prints for components, equipment, and/or new designs, review, control, and track print updates for accuracy.
• Interact with engineering, management, site, and corporate team members, and/or vendors to develop engineering controls or required process improvements.
• Plan, coordinate, or perform modifications, improvements, or new initiatives for new or existing products, equipment, or processes.
• Collaborate with Tooling Supervisor to find solutions in tooling design, improvements, preventative maintenance opportunities, or process parameters.
• Support current and future projects as related to measurement devices; qualify new or improved measurement devices to support production and quality.
• Conduct and design engineering studies and ensure all changes are appropriately documented in change controls or other methods of documenting change.
• Apply lean manufacturing initiatives, identifying product failure reduction opportunities, standardizing processes and parameters, and identifying cost savings potential.
• Support projects and initiatives stemming from the Local and Global Process Engineering Team.
• Research and analyze data to determine optimal processing conditions.
• Contributes to continuous process improvement efforts.
• Use statistical methods and good documentation skills to ensure evaluation is completed with the necessary information.
• Initiate, support and execute process related CAPAs for Quality Initiatives or Customer Complaints.
• Must have good communication skills while working with operators, engineers, and management.

• Bachelor's degree in engineering required

• Minimum of 1-3 years equivalent experience in cGMP/Pharmaceutical manufacturing environment.
• Minimum 1-3 years’ experience of AutoCAD, SolidWorks, and GD&T.
• Six Sigma and Lean Manufacturing experience preferred
• Project management, ability to work independently required
• Machining, Tooling, Engineering Materials, and Finishing (plating and surface treatments) experience preferred

• General knowledge of OSHA/EPA/safety regulations, manufacturing, and process automation.
• Maintain an awareness of “state of the art” technology as it applies to our industry. Take part in educational programs pertinent to process projects.
• Working knowledge of business and shop floor systems to effectively manage operations; prefer SAP, Minitab, and MS Office applications.
• Experience working with ISO9000, FDA and cGMP required.
• Understanding and experience in use of Lean manufacturing principles.
• Ability to write routine reports, correspondence, and process documents.
• Excellent organizational and communication skills.
• Works independently with minimal guidance.
• Able to be aware 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 preferred

• While performing the duties of this job, the employee is regularly required to, sit, stand, walk, talk, hear, see and use hands and fingers 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 employee occasionally works in clean room environments requiring special gowning and training to operate in these environments.
• 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 as posted 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, etc.