דרושים Sr Specialist Regulatory Affairs Md ב-West Pharma ב-United States, Tempe

• Mentor and may lead engineering team to achieve site and department goals in a fast-paced environment.
• Collaborate with cross-functional teams to develop and implement sustainable manufacturing processes and systems.
• Technical and hands-on automated equipment troubleshooting, repair, and improvements.
• Perform and document engineering studies and evaluations.
• Analyze data to drive improvements, determine prioritization, and identify opportunities.
• Lead and provide mentorship in root cause and corrective action (RCCA).
• Assess and perform/schedule technical training, including electromechanical systems, pneumatics, servos, PLCs, schematic reading/interpretation, new technology, etc.
• Champion high-visibility projects. Develop project scope, timeline, savings, and cost estimations.
• Quote new automation lines, engineering services, etc. Develop design concepts for new automation.
• Write validation, user requirements, equipment specification, and other documents as needed.
• Establishes relationships with customer and automation suppliers in pursuit of win?win results and ongoing business.
• Provide engineering assistance to assure plant, machinery, and processes are at an optimum level.
• Routinely evaluate and review employee performance.
• Promote and support a Lean Manufacturing environment within the facility.
• Research new technologies and methodologies to use in the plant.
• Provide a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Perform other duties as assigned based on business needs.
• Conform with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibit regular, reliable, punctual and predictable attendance.
• Other duties as assigned.

• Bachelor's Degree In Engineering or Science field required
• Master's Degree In Engineering or Science field preferred

• Minimum 5 years 5-8 years of experience required and
• 2+ years of managerial or supervisory experience in manufacturing environment required and
• Strong automation background and experience with CAD and SAP systems a plus. preferred

• Knowledge of manufacturing processes, workflows, production equipment and industrial techniques.
• Must have effective problem solving and interpersonal skills.

• Manufacturing\Six Sigma Green Belt Certification Six Sigma green belt Upon Hire preferred or
• Manufacturing\Lean Six Sigma Black Belt Six Sigma black belt Upon Hire preferred

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

In this role, you will be able to be a self-directed operator with good leadership skills and the ability to assist the Production Shift supervisor in the daily schedulingperations and evaluation of production staff assigned to their work grouup. Coordinates and/or assists in all materials, production, quality and documetation of raw materials and finished parts with Supervisors, Material Handlers, and Production Engineering. Assists the Supervisor in training, coaching and performance evaluations. Assissts as needed in the Supervisor's absence.

• Assist and directs the activities and resources of daily production assigned to the work group including; interviewing, work assignments, break scheduling and relief, and shipping and packing label generation.
• Maintains a clean, orderly and safe workstation and environment at all times.
• Establishes team objectives and measurements for production, calculates and compares production results with daily production reports, and enter results in ERP system.
• Coordinates with other departments to ensure variety of production necessities such as; documentation, labeling, packaging, part quality, equipment control(s) are set and functioning correctly, and line changes are completed for changes in production and/or customer specifications.
• Coordinates with the other Production Leads and Shift Supervisor on all production and personnel matters as needed to meet work objectives.
• Lead continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste within the production environment.
• Follows all applicable SOPs, GMPs, and DOIs.
• Contributes to continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste.
• Supports and contributes in Lean Sigma programs and activities towards delivery of the set target.
• Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.

• Conforms with and abides by all regulations, policies, work procedures, instruction, and safety rules.
• Complies with the company’s quality policy at all times
• Maintains a clean, orderly and safe workstation and environment at all times.
• Ensures Daily, Weekly, and Monthly cleanings are performed, and documented per procedure.
• Exhibits regular, reliable, punctual and predictable attendance.
• May be required to work mandatory overtime and/or irregular hours and/or on irregular days to complete assignments and meet business needs.

• Performs other duties as assigned.

• High School Diploma or GED

• Minimum 18 years of age
• Able to read, verbalize, and understand procedures, safety sheets, instructions, and policies in English
• Experience: 1-3 years of experience, ideally in manufacturing and/or clean room environment
• Experience in manufacturing as a competent ooperator/inspector

• Experience with GMP practices, ISO, and medical device manufacturing
• Experience supervising others

• Will be required to follow hygiene and gowning requirements and wear protectice clothing over the head, face, hands, feet and body. Must adhere to standards. Must work constructively in an environment that may be stressful while at times maintaining company confidentiality.
• Requires occasional bending at the waist, twisting (at the torso and neck), crouching, climbing, kneeling, balancing, reaching (including overhead), pushing, pulling, grasping, holding and manual dexterity.
• Ability to understand verbal or written directions, which may include reading English and understanding symbols and warnings.
• Must be able to multi-talk, work under time constraints, problem solve, and prioritize.
• Must be able to work scheduled work week, plus overtime and/or irregular hours as required to complete assignments. May stand or sit for extended perriods of time.
• Must transport oneself to and from other areas of the faciity and travel to other divisions when necessary.
• Must have good visual acuity. If specidically 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 and react to audible alarms from distances up to 150 feet.
• The ability to be able to lift and carry various items up to 50 lbs. for manufacturing positions or 30 lbs. for administrative positions is required.
• Office or manufacturing environment, depending on position's location.

• 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

• Strategically develop production plans in coordination with the Regional Planner/s and direct plant personnel in the execution of the approved plans --- following their review and approval at the monthly Sales and Operations Planning (S&OP) meeting.
• Directs the teams that develop and executes production, inventory, and material plans.
• Adheres to monthly S&OP schedule in providing inputs & managing outputs and participates in all required production and supply chain/customer meetings.
• Collaborates with the regional planner & demand analyst to understand customer demand (inter-company included) and market drivers to facilitate a balancing of capacity (tool, machine and labor), inventory and delivery lead-time in the development of the production plan.
• Partners with the regional planner to aggregate the plant Master Production Schedule (MPS), incorporate forecast & market demand and develop a production plan (VOLUME).
• Implements and oversees vendor managed inventory (VMI) programs.
• Executes Rough Cut Capacity Planning (RCCP) for key resources (tools, machine, labor and material) to establish that the Production Plan is achievable and to recommend the need for additional resources.
• Works with the strategic supply planner to develop and maintain a program to manage raw material sourcing routine for an optimal balance between inventory, cash flow and transportation cost.
• Provides strategic direction and guidance in planning for conversations related to purchasing of raw materials.
• Manages the customer order cycle and communication between plants, headquarters and the customer.
• Monitors manufacturing lead times and delivery performance to assure targeted customer service levels are being achieved.
• Provides oversight and strategic leadership on slow moving and obsolete inventory.
• In the absence of packaged solutions, develops and implements PC/Microsoft based tools.
• Leads effective product transfer plans and supports database coordinator to ensure the integrity and accuracy of the ERP and MES data.
• Develops and manages the training, growth, development, and succession planning for the Supply Chain Department
• Support and contribute to Lean/Six Sigma programs and activities
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Performs other duties, as assigned based on business needs.

• Bachelor's Degree Supply Chain, Engineering, Finance, or Business required
• Master's Degree MBA preferred

Minimum 10 years (Sr Mgr)experience in operational management in the medical device/pharma/plastics injection industry,Prior manufacturing experience in an industrial /cGMP setting andExperience in lean manufacturing systems and costs savings programs which affect company financial and growth plans are Required.

• Manufacturing\Certified in Logistics, Transportation, and Distribution (CLTD)-APICS preferred
• Manufacturing\Certified in Production and Inventory Management (CPIM)-APICS preferred

• Able to sit and/or stand for extended periods
• Able to be able to lift and carry various items up to 40 pounds
• Able to climb stairs and ladders
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Must also be able to maintain confidentiality and resolve conflicts.
• Ability to make independent and sound judgments.
• Read and interpret data, information, and documents
• Analyze and solve problems and interpret situations
• Work under deadlines with constant interruptions

• Lead project planning activity and develop comprehensive project plans including scope, timelines, budget, resources, and project success criteria. Gain buy-in from project team and ensure an inclusive approach to project planning. Proactively identify gaps and risks to project success and implement mitigation strategies to minimize impact.
• Collaborate with cross-functional teams, internal and external to the laboratory, to coordinate project execution and ensure that project objectives and success criteria are met.
• Provide Quality Engineering direction to multiple concurrent product development programs to ensure product and process compliance to all applicable regulatory and cGMP requirements, including ensuring all relevant safety procedures are employed.
• Author, review, and/or approve design history documentation and design manufacturing documentation (e.g., product specifications, design verification and validation activities, FMEA risk documents, test methods, protocols, reports, manufacturing records, etc.)
• Lead the development and maintenance of product or process risk and hazard analysis in accordance with West policies and procedures and ISO standards.
• Lead and manage QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, audit findings, issue reviews, document control, change controls, configuration management, etc. Provide direction on any nonconformance, deviation, or excursion that may occur and drive to closure. Author and review product development QMS procedures and work instructions.
• Meet company and departmental goals in the continuous improvement of all products, services and processes, including the West QMS.
• May work independently and with project teams to develop design control deliverables including quality plans, manufacturing and inspection documentation, test methods, and any other necessary quality records. Provide quality reports and review trending on assigned areas of responsibility.
• May support quality assurance improvement activities by evaluating products, processes or materials in order to develop control or improvement strategies intended to improve the customer’s experience.
• May assumes responsibility for various assigned projects designed to improve product quality, reduce costs and/or validate facility products or processes, including development and implementation of any new or required inspection methods and in-process Statistical Process Control programs.
• May perform DOEs (Design of Experiments) to help improve and optimize new and/or existing plant processes or job protocols, and identify and remedy equipment and/or process documentation gaps and provide appropriate training where needed.
• May have people management responsibilities.
• Other duties as assigned.

• Bachelor's Degree in Engineering or Science or equivalent experience required

• Minimum 5 years of experience in a regulated industry (e.g., Medical Device), including Product Development, Product Manufacturing, and Post Market Surveillance Activities required and
• Demonstrated experience (4+ years) independently defining, planning, and executing projects in highly regulated environments with a track record of success required and
• In-depth knowledge of cGMP regulations, ISO 17025, ISO 11040, ISO 13485, 21 CFR 820, ISO 14971 required and
• Proficiency in standard project management tools and software (e.g. Microsoft Project, Excel) for planning, tracking, and reporting project activities, and proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point required and

• Experience with MasterControl, SAP, Share Point, Teamcenter
• Experience with ISO 11040, ISO 11607
• Expertise in quality management tools. Standards, policies, and procedures – APQP, PPAP, MSA, SQC etc
• Strong working knowledge of quality systems of the respective ISO norms
• Working knowledge of supplier quality management from product development to mass production.
• Strong project management skills
• Proficient in computer system applications (SAP, master controls, etc) communication skills
• Excellent critical reading and writing skills
• Problem solving including root cause failure analysis methods
• Be aware of all relevant SOPs as per Company policy as they relate to this role
• Able to comply with the company’s safety and quality policies at all times

• Manufacturing\Six Sigma Green Belt Certification or Black Belt Upon Hire preferred
• Quality\Certified Quality Technician-ASQ (CQE or CQA) Upon Hire preferred
• SO 17025 Auditor or Lead Auditor Training / Certification Upon Hire preferred

• Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• Excellent written and oral communication and interpersonal abilities, with the capacity to communicate complex technical concepts to diverse stakeholders.
• Ability to work independently, multi-task and thrive in fast-paced environment.
• Strong problem-solving skills including root cause failure analysis methods.
• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
• Must maintain the ability to work well with others in a variety of situations.
• Critical reading skills and maintain high attention to detail, accuracy, and overall quality of work.
• 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.

• 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.