דרושים Production Manager ב-West Pharma ב-ארהב

• Overall ownership and accountability for developing, leading and driving new business development for DDD OU product platforms for identified strategic accounts to achieve revenue growth targets for commercial and product development sales.
• Advance the vision for strategic partnerships and customer opportunities as the SME for device services offerings, for all direct assigned accounts and regions. Establish business development programs including early adopter customers, target service levels, and CDAs (Customer Development Agreements).
• Responsible for driving the prospecting and lead development, monitoring sales and funnel performance. Lead and support customer facing teams in key customer interactions/strategic partnerships throughout the selling journey including critical customer/strategic collaboration, presentations, post-sales leadership and problem solving to deliver on revenue and growth targets.

• Bachelor's in Engineering, Science or Business-related discipline

• Minimum 15 years of experience in B2B, Combination Products, Business Development, Product/Program Management.
• Indepth knowledge and experience in pharmaceutical/medical device technical development, sales, marketing or related business.
• Experience in successfully leading global multi-functional or cross-functional teams, in developing cohesive relationships and producing strong business results.
• Excellent communication/negotiation/influencing skills and strong customer focus.
• Excellent commercial and financial acumen.
• Self-starter, highly motivated and ability to work independently with little or no daily supervision.

• MBA or master’s degree preferred
• Background with a good technical understanding and knowledge of Combination products, medical device qualification, primary packaging, Regulatory requirements and Program Management.
• Significant leadership team experience and executive leadership exposure.

In this role, the Quality Project Manager will support the standardization of QMS process and data management across the organization. This position will lead the development and deployment of quality maturity, QMS improvements and quality cost related measures, evaluations, performance, and initiatives. This position will coordinate activities associated with quality maturity including continuous improvement projects relating to sustaining engineering activities, development of new methods/processes for product evaluation and product development activities through a standardized approach. In addition, this position will deploy highly capable, predictive, effective, and efficient quality cost metrics for West Pharmaceuticals. This position will also be responsible for leading and executing cost improvement initiatives, follow up assessments and action oversight.

• Lead the initiative to standardize quality systems between multiple sites. Identify best practices and ensure roll out to relevant sites.
• Organize and generate detailed quality information reports to show trends and the impact of process improvements.
• Create repeatable methods to assess, measure and communicate the overall quality of a project and deliver key metrics to assess the overall improvement.
• Establish and lead cross functional quality related meetings to review and discuss performance, status and prompting necessary actions as required.
• Manage goals and metrics for Quality teams/initiatives to adequately monitor the overall effectiveness of the teams/initiatives.
• Work with project managers, engineering team, and platform management to develop plans to implement improvement projects.
• Ensures teams work closely with product development, supplier/contractors, design, quality, regulatory teams in order to establish standardized KPIs.
• Work within Quality or across West Divisions to triage Customer Operational difficulties, define root cause(s), and coordinate the implementation of corrective and preventive actions to preclude recurrence related to quality improvements and quality maturity.
• Manage or contribute to both corporate and facility driven initiatives intended to meet defined objectives.
• Support front room and or backroom responsibilities during external audits. Including post audit activities, if required.
• Responsible for assembling a project team, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely completion of project.
• Record detailed customer requirements, constraints, and assumptions with stakeholders in order to establish the project deliverables.
• Responsible for project budget estimation, monitoring, and attainment throughout the project lifecycle.
• Ensure a common understanding by setting expectations in accordance with the project plan in order to align the stakeholders and team members.
• Lead the identification, assessment, monitoring, and closure of project risks throughout the project lifecycle.
• Manage changes to the project scope, project schedule, and project costs using appropriate verification techniques in order to keep the project plan accurate, updated, and reflective of authorized changes to facilitate customer acceptance.
• Responsible to improve team performance by building team cohesiveness, leading and motivating in order to facilitate cooperation, ensure project efficiency, and boost morale.
• Measure project performance using appropriate tools and techniques in order to monitor the progress of the project, identify and quantify any variances, perform any required corrective actions, and communicate to all stakeholders.
• May coordinate the activities of one or more exempt and/or non-exempt employees.
• All other duties as required.

• Bachelor's Degree in Science, Engineering or related field

• 8+ years of relevant work experience required

• 5+ years’ experience in pharmaceutical or medical device environment.
• 2+ years’ experience in a Quality role.
• ASQ CQE certification desirable.
• Deep knowledge of quality processes such as CAPA, complaint management, risk management, root cause analysis, statistical sampling plans, FMEA/Fault Tree Analysis, Design Optimization using DOE, Hardware Reliability, Software Reliability, and Design Controls including Design Verification/Validation.
• Knowledge of ISO 9001:2008, ISO 13485, 21 CFR 820, 21 CFR 210 & 211, cGMP, cGLP.
• Ability to manage direct report(s), work independently and in a team environment.
• Demonstrate innovativeness in tactical matters relating to proposing alternate solutions for process improvement.
• Experience in FDA regulated environment, pertinent to ISO 13485 is preferred.
• Experience with SAP is preferred.
• Support and contribute to 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.

• • 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.

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

• 5-8 years of experience in a manufacturing environment, including supervisory experience

• 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

• 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.

• High School Diploma or GED required

• 1-3 years manufacturing experience preferred

• Must possess an acute attention to detail
• Basic computer skills, i.e. use a mouse/keyboard.
• Ability to apply Good Manufacturing Practices (GMP)
• General use of computer work station and ability to use SAP commands is preferred
• Must be willing and able to work as a team member and make general decisions within authorized job responsibilities
• Must be able to train and guide others as required.
• Must be able to read and write in English

In this role you will coordinate business unit lean savings, goals and objectives through the use of statistical techniques by planning, scheduling, and executing process projects. You will communicate project status, and define and shape strategic planning efforts, including critical goal and objective development that identifies and improves critical processes necessary to achieve annual targets, including waste reduction to drive technical and operational improvement. This role will focus on coordinating, managing, and driving all transformation initiatives across site, ensuring alignment with both site’s and operational goals and the corporate stakeholders’ broader strategic objectives.

• Oversee the planning, execution, and delivery of all transformation projects, ensuring they are completed on time, with scope and within budget.
• Establish clear metrics and KPI’s for each transformation initiative, regularly tracking and reporting on progress to SLT and key stakeholders.
• Participate in the development and support of the West Business System (WBS), with the goal of sustaining operational standards on the site.
• Develop and communicate a comprehensive transformation strategy that aligns with the site growth targets, technical & operational capability imperatives, operational excellence objectives and the Operating Units vision.
• Provide thought leadership and direction for all transformation activities, ensuring they are prioritized, scheduled, and executed effectively.
• Create strategic plans to eliminate waste within the business unit by utilizing lean processes, key performance indicators, metrics, cost savings, best demonstrated practices and enterprise resource management.
• Create and execute a robust change management framework that prepares the site and its employees for upcoming changes, minimizes resistance, and maximizes adoption of new processes and technologies.
• Ensures that all transformation initiatives are supported by effective communication plans that keep all stakeholders informed and engaged.
• Develop robust, capable systems necessary to achieve the strategic goals and objectives and drive excellence through the manufacturing operations; assure that production processes are repeatable and capable of meeting specifications, by ensuring the consistent and uniform application of OPEX tools.
• Provide leadership on lean thinking and lean processes to ensure established goals and objectives are met and provide methods to monitor processes to assure they remain in control.
• Assist in the training and guidance for lean champions and team members to develop and implement Lean action plans and transfer lean initiatives to other West plants.

• Bachelor’s in engineering, Statistics or recognized equivalent required
• Master’s Degree in related field preferred

• Minimum 10 years (Sr Mgr) in related field required
• At least 5 years of experience in a manufacturing/production environment required
• Must possess a Six Sigma Green Belt certification and have at least 5 years of experience demonstrating and using Six Sigma/Lean tools and methodologies required
• Medical Device industry experience preferred

• Must have good interpersonal/leadership skills and be able to interface with all departments and team member levels.
• Must have excellent organizational, interpersonal and problem-solving skills and be able to interface with employees at all levels of the organization.
• 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.

• Safely work in construction environments
• Noise level in the work environment while on the production floor is usually moderate to loud. Hearing protection is required.
• Must follow and comply with Plant’s Dress and Hygiene Code (SOI)

Management and implementation of facility projects and support in holistic building management. Perform a wide variety of mechanical, as well as pneumatic maintenance activities and some basic electrical activities on various pieces of equipment to maintain safe operations of equipment while maintaining production goals and quality standards. Other responsibilities include sourcing parts for obsolete parts and ordering them, documenting all the maintenance activities performed, PM's, installation, and validations of equipment. Will support and help other groups like Process Engineering, QA, and Facilities in resolving problems, improvements, investigations etc. In this role you will service/maintain several machines, while learning the others in the department. Work from prints, sketches, sample parts, verbal or written instructions. Interpret drawings, select material plan, and layout work in proper operational sequence. Maintain and setup vision systems during production.

• Identify problems by reading schematics/prints, where available, and make necessary repairs on the equipment or system to ensure safe operation of the machine or system.
• Respond to production maintenance request and any unscheduled down time.
• Troubleshoot and adjust or repair ancillary equipment like blow overs, bulb pullers, and heaters.
• Changeovers and setups on Vision Systems, make minor adjustments as required.
• Perform ink mixing as well as disposing of procedure as per set Safety/QS guidelines for printing machines.
• Perform necessary oil changes on machine gear boxes and dispose of used oil per established procedure.
• Rebuild/retrofit machine or machine components as per specifications.
• Perform installation, replacement or decommissioning of equipment.
• Perform validations as necessary for equipment.
• Work with training department to train new mechanics on machine repair, setup and related plant procedures.
• Complete PM's on or before the due date and communicate to proper authority of job completion.
• Source obsolete parts for equipment and make them stock item.
• Identify and locate parts in the stock room through MP2 or other such system.
• Participate in various company run programs like Continuous Improvement, Safety initiatives, audits, investigations etc.
• Support projects and improvement initiatives from engineering, process, QA, Safety and Operations groups.
• Document performed tasks for the day into the maintenance log before the end of each shift.
• Safeguard all corporate or plant confidential information.
• Use good housekeeping practices to maintain safe, (safe is always first) clean, orderly work area.
• Upgrade technical skills by various educational workshops, on-site or off-site trainings supported by WEST.
• Follow engineering department guidelines and procedures.
• Conforms with and abides by all safety rules, regulations, policies, work procedures and all instructions.
• Exhibits regular, reliable, punctual and predictable attendance.
• Implementation and collaboration of facility projects

• High School Diploma Or GED required

• 3 years manufacturing maintenance experience

• Experience with plastic injection molding preferred.
• Experience with robots and pick in place robots.
• Experience with ISO 9000 standards and GMP’s.
• Excellent communication and interpersonal skills.
• Experience with SAP or similar software for maintenance tracking.
• Agile working style.
• Ability to work weekends and overtime as required

Responsible for providing expertise in Quality Assurance processes related to the manufacture of West products. Ensure compliance with regulatory requirements and West procedures. Proactively develop, lead, and drive the execution of the Quality Assurance strategy. Develop and implement quality assurance plans ensuring compliance with regulations, oversee interactions with regulatory agencies and build strong relationships with internal and external stakeholders. Champion advocacy for product, process, and system quality, and drive continuous improvement within the Quality Management System.

• Reporting to the Sr. Director, Quality Assurance, the role will play a critical part in the company’s business planning / strategy development.
• As a member of the Site Leadership Team, deeply engages and effectively contributes to the achievement of site objectives by playing an active role in the strategic planning processes
• The role will also have a dotted line reporting relationship to the Director, Operations, Williamsport to ensure development and alignment of the site business plan including support to the other senior managers in the execution of same
• Maintain a positive working relationship with internal and external stakeholders by supporting validation in design and development, specification development, and execution of manufacturing programs in line with agreed standards. All the while ensuring that West’s product quality and reliability meets or exceeds customers’ expectations.
• Directs and manages quality control, quality assurance, quality systems, metrology and/or regulatory affairs, personnel, department resources, and continuous improvement efforts to achieve the most efficient quality output possible.
• Partner with organizational leaders and drive quality initiatives, systems, and methods to meet quality objectives. Meet company and departmental goals in the continuous improvement of all products, services, and processes, including the West QMS. Support QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, and audit findings.
• Perform the necessary functions in support of the Williamsport Quality System
  • Designated ISO 13485 Management Representative
  • Designated back-up to QA Supervisor for HACCP Manager and SQF Practitioner.
• In accordance with US and other regional/ country legislation, act as Head of Quality Control/ Head of Quality/ Official Correspondent on all government agency issued authorizations, communications and registrations.
• Cultivate a positive working relationship with the West Customer base via supporting validation in design and development, agreeing specification, execution of manufacturing and programs in line with agreed standards. All the while ensuring that the West’s product quality and reliability meets or exceeds customers’ expectations
• QA representative participating in customer face to face steering committees and business review which originate from site customer base. Chairing customer meetings with respect to Quality standards and expectations.
• Champion a quality/ patient first organizational culture that promotes behaviors that lead to superior quality and business performance and enterprise excellence.
• Participate in customer, regulatory, and internal audits of the plant; participate in supplier audits and participate as part of the Corporate Cross Site Audit Team.
• Review and assist on the updating of customer specifications. Respond to customer/sales regarding the approval or recommended changes to these specifications and maintain a file of the responses and the specifications.
• Oversees complaint handling, non-conformance management, internal and external audits, and CAPA system to ensure timely and compliant systems. Evaluates and provides for audits of external and internal quality systems and their functions, insuring follow through and corrective actions.
• Establish, monitors, and provides weekly / monthly progress of the Quality KPIs and communicate it to the organization and senior management.
• Responsible and accountable for quality departmental budget
• Other duties as assigned

• Bachelor's Degree in engineering, mechanical engineering, chemical engineering, manufacturing engineering, industrial engineering or equivalent experience required
• Master’s degree preferred

• 10+ Years of job-related experience required in the Medical Device or Pharmaceutical Industry.
• 8+ Years of supervisory experience required.
• 5+ Years of experience working with injection molding processes preferred.
• 5+ Years of experience in an FDA or ISO regulated industry required, preferably in medical device manufacturing.

• Regulatory Skills: In-depth knowledge of medical device and pharmaceutical regulations and guidelines, including cGMP, ICH guidelines and other relevant regulatory requirements (e.g. HACCP).
• Leadership Skills: Strong leadership and management skills with the ability to lead cross-functional teams, drive initiatives, and influence stakeholders at all levels of the organization.
• Communication Skills: Excellent communication skills, both written and verbal, with the ability to effectively communicate requirements and strategies to diverse audiences.
• Analytical Skills: Strong analytical and problem-solving skills, with the ability to analyze complex problems, identify root causes, and develop effective solutions.
• Adaptability: Flexibility and adaptability to navigate changing regulatory landscapes and business priorities.
• Ethical Standards : Adherence to ethical standards and integrity in dealing with regulatory agencies, colleagues, and stakeholders.
• Self-motivated with a proactive attitude and the ability to work effectively
• Project Management experience preferred

• Excellent communication and interpersonal skills must be coupled with public speaking, quick decision making.
• Excellent written and oral communication skills
• Medical component and device manufacturing require strict adherence to standards.
• Strong communication and technical writing skills, interpretation of data, interpersonal skills, ability to work on and lead teams
• 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
• Demonstrates enthusiasm, takes accountability, and drives for results.
• Superior organizational and leadership skills with ability to help team grow and thrive
• Able to lead and front multiple third party Medical Device / Pharmaceutical audits.
• Able to interact with global Medical Device / Pharmaceutical agencies in support of queries / product launches.
• Have in-depth / working knowledge of: ISO 13485, US FDA 21 CFR Part 820, ISO14971
• Have strong self-motivation, the ability to work independently, and within a team environment with strong follow up, organization and prioritization skills and excellent attention. Must have a proven track record of developing and maintaining positive customer relationships.
• Able to lead and manage the performance of a multi-functional team.
• Able to organize and prioritise tasks, must be detail orientated and self-motivated.
• Have excellent written and verbal communication skills. Must be able to work in a fast paced environment.
• 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 always comply with the company’s safety and quality policy