דרושים Senior Manager Human Resources Business Partner ב-West Pharma ב-United States, Tempe

• 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

• 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.

• 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

• 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.

• 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

• Provide leadership defining the strategy in support of long-term and intermediate goals within Global Process Development in collaboration within the Global Contract Manufacturing and Technology Network.
• Develop scope of work, plan and manage for Injection Molding/Equipment Validation projects for the introduction of all new products into the company and compiling standard specifications for each process and monitoring all existing production to standard specifications.
• Use strong analytical skills to understand and implement customer/user needs, market requirements and other design inputs.
• Support CM Sales team in all new business quoting and gathering customer requirements relating to Process Engineering requirements.
• Identify, execute, and implement process improvement initiatives across the Global platform.
• Provide leadership/guidance on the installation and validation of new equipment/process development through SAT/IQ/OQ/PQ.
• Ensure that the procedures and systems are in place to facilitate the introduction of new processes and equipment.
• Drive idea creation, development, bread boarding/prototyping, feasibility testing, etc. to evaluate viability of ideas.
• Lead and advise component material selection with a strong emphasis on polymer selection for injection molded parts.
• Hands-on engineering, such as reverse engineering, simple assembly and machining work, component testing and failure analysis

• Provide continuity for the validation program for assigned plant or functional area by preparing technical documentation/presentations. Provide project leadership for materials / process related projects by coordinating the efforts of the various departmental disciplines for the successful completion according to plan and budget
• Managing internal and external resources to meet the technical requirements of the project, such as outside vendors, and management of techs and/or interns
• Work with Tooling Design team to plan innovative technical approaches to design solutions
• Coordinate engineering meetings with manufacturing plants. Identify, monitor status of results or projects.
• Leveraging internal and external resources to solving complex problems
• Help execute specific strategies, tactics and action plans for the location, as part of the overall Delivery Systems/Innovation product development plan, inclusive of management/ tracking of project activities and resources

• Bachelor's Degree in Engineering or another scientific area or equivalent experience required. Preferred Plastics
• 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
• Good know-how and experience in Project management required
• Regulatory compliance in cGMP manufacturing and testing of Pharmaceutical or Medical Device Products.
• Ability to manage projects, teams, maintain timelines, and execute projects in a Global Engineering environment

• Expertise in injection molding techniques, methodology, and trouble-shooting methods; a deep understanding of equipment, process, and tools relating to injection molding
• Must have excellent written and verbal communication skills as well as the ability to accurately document work performed.
• Experience working with teams and influencing decisions
• Must have an in-depth knowledge of Statistical Process Control (SPC) and Design of experiments (DOE) and demonstrate use of same.
• Excellent understand of the Scientific approach to Injection Molding
• Preferred understanding of EDARTS, RJG Master Molder certificate
• Must have knowledge in computer systems; integrated manufacturing systems; word processing and spreadsheets
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Must be able to organize and prioritize tasks; must be detail orientated and self-motivated.
• Must be able to deal with all levels of employees and work across various departments.
• Experience in writing and executing validation protocols and reports,
• Ability to function as a team member.

• 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

Thisrole will support team members, enable growth, provide high touch employee service, and be an advocate of West's culture and mission. You will be a trusted advisor to our departmental leaders, partnering to build and strengthen their high-performing teams and ensuring we are making the right people decisions. You will support our employees as a true advocate to help them grow and thrive. This position carries out responsibilities in the following functional areas: benefits administration, employee relations, training, performance management, onboarding, policy implementation, recruitment/employment, affirmative action, and employment law compliance.

• Provide HR business partner support across all assigned business clients within designated location.
• Support the implementation of global human resource initiatives under the direction of the HR leadership team.
• Provide the appropriate HR support in the acquisition, development and retention of talent, working in close collaboration with talent acquisition teams; including back ground checks, scheduling interviews, greeting candidates upon arrival, new-hire onboarding, etc.
• Provide HR clarification around benefits, payroll, HR policies and practices to employees.
• Enter employee information into the HRIS system for processing (i.e., new hires, terminations, promotions, leave of absences, etc.).
• Support HR in performance management cycles within the West Talent Gateway system, including gathering data and sending emails to ensure compliance.
• Site administrator back up for Learning Management System including scheduling online learning classes, tracking attendance and maintaining files.
• Serve as HR liaison between the local and global HR functions depending on business issue. Ensure that consistent practices are maintained between HR and the business.
• Actively participate in HR forums to further progress the organization’s HR value proposition.
• Consults with managers and supervisors regarding employee performance issues and assists with the disciplinary process by helping conduct employee termination discussions and mediating and assisting in solving employee performance and/or work issues.
• Collaborating with managers and Corporate HR Compensation on job reclassifications and writing of job descriptions.
• Conducting workplace investigations, including cases related to discrimination and sexual harassment, and escalates to HR Manager and Plant Manager.
• Workplace planning to include assisting with and identifying personnel and training needs.
• Uses data, statistics, evidence-based research, benchmarks, HR and business metrics to facilitate decision-making.
• Participate in weekly plant GEMBA walks, be visible and accessible to all team members.
• Other duties as assigned.

• Bachelor's Degree in relevant business or human resources discipline required.

• Minimum 3 years HR experience or equivalent education required.
• Experience with HR business systems (i.e. Ultimate, SuccessFactors, SAP HCM) and MS Office applications preferred.

• Proficiency in MS office (Word, Excel, PowerPoint).
• Team player actively contributing to positive team spirit.
• Excellent verbal and written communication skills.
• Works to the highest level of professional standards.
• Self-Organization, time management and prioritization.

• SHRM certification. Upon Hire preferred

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• While performing the duties of this job, the employee is regularly required to talk or hear.
• Regularly uses hands and fingers to operate computer keyboard.
• Must follow and comply with Plant’s Dress and Hygiene Code (SOI).

• Provide HR Leadership and direction for the site/multiple sites within your scope of responsibility.
• Supervise and provide guidance to direct reports.
• Approve hiring, firing and investment requests; and manage overall HR financial budget.
• Develop organizational objectives and facilitate goals creation for broader functions.
• Work with senior management and other peers for strategy development and execution plan.
• Guide the talent identification and development processes.
• Oversee employee performance and communicate goals results.
• Use in-depth expertise and experience to provide HR manager business partner support for various HR initiatives: performance and talent management, change management, workforce planning, leadership and employee development, onboarding and offboarding, compensation planning and benefits administration.
• Act as a trusted senior advisor to provides advice, clarification and follow-up on policies, procedures, benefits and compensation related items for employees, managers and global HR partners. Interprets and administers HR policies, procedures, guidelines and programs, always ensuring alignment with global West in a consistent manner.
• Perform other duties as assigned based on business needs.

• Bachelor's Degree in Business, HR or related field required
• Master's Degree in Business, HR or related field preferred

• Minimum 10+ years of experience in Human Resources and role of HR generalist and or HR manager required
• Deep experience and knowledge of multiple HR disciplines preferred
• Experience with HR business systems preferred

• Leadership.
• Change Management.
• Wide knowledge of federal and state employment law.
• Strong consultative, interpersonal and client orientation skills.
• Ability to work both independently and in a team environment.
• Capacity to handle confidential and sensitive information and issues in a discrete manner.
• Ability to work in a fast-paced virtual environment in a global organization.
• Trustworthy, inclusive, communication and presentation to diverse and large audiences, decision making, planning and organizing, personal accountability and attention to detail.
• Ability to prioritize and respond timely to changing requirements and to coordinate multiple tasks simultaneously.
• Knowledge of MS Office applications.
• 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 and quality policies

• Human Resources\PHR or SHRM-CP Upon Hire preferred
• DDI certifications. Upon Hire preferred

• 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.
• Position operates in a professional office environment. May stand or sit for extended periods of time.
• This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
• 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.