דרושים Engineering Lab Manager R&d ב-West Pharma

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.

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)

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

In this role, you will be responsible for performing highly diversified duties to install, troubleshoot, repair and maintain production equipment according to safety, predictive, and productive maintenance systems and processes to support the achievement of the site’s business goals and objectives.

• Provide emergency/unscheduled repairs of all manufacturing equipment during production as well as performing scheduled preventative maintenance of the same.
• Perform mechanic skills including, but not limited to, mechanical, electrical, pneumatic, hydraulic, troubleshooting and repair of production machines.
• Maintains and updates equipment documentation regarding repair/adjustments.
• Be able to comprehend equipment manuals, electrical wiring diagrams, hydraulic drawings, and mechanical drawings.
• Be able to provide required fabrication of various shields and guards. Ability to bend, cut, shape, weld.
• Diagnose problems, replace or repair parts, test, and adjust.
• Interface with manufacturing engineering to implement process improvements.
• Use a variety of hand and power tools, electric meters and material handling equipment in the performance of your duties.
• Be available to work various shifts, including overtime and weekends when necessary. To share call in duties with others assigned.
• Actively participate and comply with all West Health, Safety and Environmental programs and regulations.
• Maintain a neat and orderly work environment in accordance with West 5S program.
• Participate in training to become more proficient in the working knowledge of and repair of incoming machinery.
• Set up and installation of incoming and new equipment.
• Other duties as assigned.

• High School Diploma or GED Required.
• Trade or Vocational School preferred.
  • One (1) year certificate from a technical school or college in a trade relating to electrical, pneumatic or mechanical; or a minimum of 3 years’ experience on the job training (related to plant maintenance); or a combination of education and experience in a trade relating to this position.

• 3 years of manufacturing maintenance experience or a combination of education and experience in a trade relating to this position.

• Ability to operate a Powered Industrial Truck.
• Ability to understand and follow company's Standard Operating Procedures.
• 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.

• Develops and implements policies and procedures for production operations
• Plans, examines, analyzes, and evaluates production operations
• Prepares production reports, reviews operating and financial data and makes recommendations for improvements
• Evaluates work performance and initiates personnel actions such as recruitment, selection, promotions, transfers, and disciplinary measures
• Resolves grievances, investigates customer complaints, and proactively participates in problem resolution
• Directs and coordinates work and production schedules and general department activities through subordinates
• Lead continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste within the production environment
• All interactions, workflow, productivity levels, and quality standards are implemented with a “Customer Service” approach to both internal and external customers
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules
• Exhibits regular, reliable, punctual and predictable attendance
• Other duties as assigned
• Commercial leadership and management of the customers allocated, including full PandL responsibility for all operational aspects
• Lead and drive the highest standards in operational performance in the development, tracking and reporting of business key performance indicators
• Build and maintain an excellent working relationship with the customer in the successful delivery of all client related projects (on time, within budget and in accordance with customer requirements/specifications).

• Bachelor's Degree in relevant engineering discipline required and
• Master's Degree in relevant engineering discipline preferred

• Minimum 8 years related experience required
• 5-10 years of experience working with injection molding processes preferred

• 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
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times.
• Strong analytical and problem solving skills
• Excellent commercial acumen and customer relationship building skills
• An ability to lead in matrix structure multiple projects on-time to budget

In this role, you will be a customer focused individual responsible for completing preventative maintenance as scheduled, on injection molds. Analytical and excellent trouble shooting skills along with a drive for continuous improvement. Interpret part prints and/or mold prints to complete quality repairs to molds and secondary equipment. Perform polishing work, operate tool room equipment, surface grinders, Bridgeport milling machines, lathes, cutter grinders and sinker EDM.

• Maintain and support existing tooling.
• Provide good centerline spacing lay out for experimental molds, commercial molds, MTD´s and devices with little to no supervision.
• Able to design experimental molds, commercial molds, MTD´s and devices with little to no supervision.
• Coordinate tooling orders for manufacturing plants.
• Good understanding of tools and processes within the individual’s region to support the West plants and other engineering departments with tooling issues, global tooling standardization questions and best practices
• Assume responsibility for various assigned projects to improve product quality and tooling designs.
• Work with cross-functional teams throughout all West locations to develop best practice standards.
• Maintain awareness of new technology trends, materials, and design/analytical software
• High understanding and aligned with company and department objectives.
• Self-sufficient and able to work with little to no supervision.
• Follow FDA, cGMP, ISO, and other applicable regulations.
• May load and unload raw materials and equipment and set up and operate a variety of machines according to instructions.
• May start and monitor machine operation to commence the production process, detect malfunctions/out-of-tolerance machining, and make any necessary adjustments to ensure product specifications are met throughout the process.
• May perform quality control, following appropriate reporting and documentation procedures.
• May transfer finished product, raw materials, tools, or equipment between work areas by using hand trucks or powered lift trucks (standing and/or sitting) and may perform routine maintenance tasks on machines as required.
• May use the ability to translate mechanical documents and engineering drawings into appropriate dimensions for production.
• May use the ability to correctly read common hand measuring tools such as outside micrometers, bore micrometers, dial indicators, etc. and inspect parts with appropriate measuring equipment to ensure results are within specification.
• May instruct fellow employees as needed and assist in the orientation and training of new employees when appropriate.
• Other duties as assigned.

• Modifies and/or constructs tools, fixtures and mold components utilizing manual metal working machinery.
• Able to perform own machine setups with no supervision.
• Troubleshoot electrical problems with Hot Runner / Valve gated systems, repair and rebuild.
• Understands form fit and function in mold construction.
• Performs close‐tolerance machining using detailed blueprints, drawings, and sketches.
• Uses precision measuring instruments in the fabrication of various metals and plastic tools and parts.
• Performs accurate layout of tolerance and angles required to complete assignments.
• Computes dimensions involving radii and compound angles.
• Recommends ideas for improvement.

• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.

• Exhibits regular, reliable, punctual and predictable attendance.

• Education or Equivalent Experience: High School or equivalent

• Minimum 5 years of relevant experience. Prior manufacturing experience in an industrial setting (pharmaceutical industry experience preferred). required
• Advanced in using SolidWorks. required
• Excellent computer skills required including all MS Office applications. required

• Good understanding in machining and fabrication equipment and methods (e.g. milling, turning, grinding, eroding, etc.).
• Familiar with cGMP, ISO, and FDA standards.
• Familiar with AutoCAD, Finite Element Analysis, Computational Fluid Dynamics, and PDM Pro.
• 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
• Trade school classes are preferred.
• Welding skills (TIG/laser)
• 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
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.

• Must be able to negotiate and effectively resolve conflicts when required
• 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
• Ability to quickly adapt to changes in a dynamic environment and must maintain the ability to work well with others in a variety of situations
• Effective personal time management skills. 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
• Must be able to speak English fluently

As the Global Equipment Compounding & Dimensioning Subject Matter Expert (SME) Leader, you will set the strategic direction and lead a team responsible for specifying, implementing, and improving equipment for weighing, mixing, and dimensioning processes in our global elastomer production facilities. You will cultivate a collaborative environment, align with cross-functional engineering teams, and drive our company’s vision for innovation and standardization in equipment processes.

• Inspire and guide the Global Compounding & Dimensioning Equipment SME team (up to 3 FTE) towards achieving organizational goals. Develop a high-performing team through mentoring and professional development.
• Lead engineering, management, plant operations and global team members while working with vendors to develop engineering specifications for new equipment or required improvements on existing.
• Shape and communicate a clear vision for advancing equipment processes, leading efforts to standardize and harmonize production equipment and associated documentation globally.
• Proactively map out and oversee team workload and project timelines to drive efficient execution of objectives, with a focus on resource optimization for new projects, corrective action/preventive action (CAPA) initiatives, and equipment development.
• Foster a culture of collaboration across various departments by working closely with Process Engineering and production teams. Facilitate the identification of innovative solutions to enhance existing systems and solve design challenges.
• Keep up to date on new and future equipment standards and trends in the market and identify value-added improvement which may be beneficial.
• Work independently, and with vendors, to understand root cause of failures, propose design or component changes, and implement and validate equipment modifications.
• Take the lead in systematic problem-solving activities if the manufacturing plants need support.
• Coordinate and/or execute all necessary GMP related validations and/or process engineering evaluations as needed for manufacturing equipment.
• Guide vendors through clear communication and task assignments. Maintain oversight on deliverables ensuring completion of Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation/Operational Qualifications (IOQ), and more.
• Champion the establishment of equipment standards aligning with global best practices to achieve unparalleled quality, efficiency, cost reduction, and safety.
• Project Management: Take the lead on equipment project management from the URS issue to PQ by applying current project managements practices including the needed GMP conform documentation.
• Research and analyze data such as vendor design proposal, specifications, and manuals to determine feasibility of design or application.
• Collaborate with cross-functional teams to follow equipment related corporate goals.
• Ensure all equipment aligns with the latest Safety Regulations.

• Bachelor’s or Master’s degree in Science or Engineering (Electrical, Mechanical, or Industrial preferred).

• Over 8 years of leadership experience in the pharmaceutical or manufacturing environments, specifically within equipment management and improvement.

• Proven track record of successful equipment project management, from specification to qualification.
• Strong engineering and trouble shooting skills.
• Proven working experience in project management.
• Demonstrated ability to manage projects in a dynamic environment with minimal direction.
• Excellent written and verbal communication skills (English & preferably a 2nd language)
• Strong strategic thinking capabilities with the ability to drive innovation and embrace change.
• Ability to drive changes and to think outside the box.
• Track record of project management excellence and great ability to perform in dynamic, autonomous environments.
• Exceptional communication skills, both in client-facing scenarios and within internal teams.
• Strong in Project and Time Management.
• Outstanding leadership and organizational skills.
• Working experience with Microsoft office products, Power BI, SolidWorks and/or other CAD systems.
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.