דרושים מהנדס QA ב-West Pharma ב-United States, Williamsport

• Prioritizing assigned workload, works independently to identify quality problems and recommend action to be taken (i.e., continuing production) based on specifications, procedures and GMP.
• Determining product acceptability by performing various visual, functional and dimensional evaluations using various types of measurement devices such as micrometers, calipers, digital or dial indicators, comparators, force testers, and torque testers to determine product acceptability.
• Providing assistance in the development of sampling plans, as required.
• Basic understanding of Statistical terminology is required to evaluate data and make a determination as to process capability; providing written summarization of study data to engineering or other groups as requested.
• Using Minitab software to create summarized data and graphs in support of engineering activities.
• Assisting in the training of manufacturing and support personnel in quality assurance related subjects, including certification to the QA equipment.
• Performing internal quality audits as part of the internal audit team.
• Support new product development working with Engineering to perform dimensional and functional testing.
• Obtaining 6S Green Belt Certification.
• Evaluating current processes for improvement opportunities.
• Performing in-process inspections in support of the manufacturing group.
• Ability to evaluate dimensional and functional test results to determine compliance to specifications.
• Performing calibration tasks for equipment and gauges in support of the Calibration Program.
• Performing raw material inspection and testing, as back –up to the Quality Assurance Inspector.
• Verify effectiveness of operator’s inspection process by performing selective product sampling audits.
• Work with Quality Assurance Engineer to design/develop fixtures for existing and new product types.

• A High School Diploma or GED is required.
• A 2-year certification in Quality Assurance or commensurate training is preferred.

• 1+ year of manufacturing experience is required.

• Demonstrate proficiency through literacy testing.
• Must be familiar with computers and various software programs such as Microsoft Word and Microsoft Excel.
  • Master Control and Mattec experience is a plus.
• Understanding of Statistical Process Control, blueprint reading, and use of measuring/testing equipment.
• Must have excellent interpersonal & problem-solving skills & be able to interface with employees in all levels of the organization; must possess good organization, time-management, negotiating & conflict resolution skills; excellent computer skills (including MS Office experience using Word & Excel) required.
• Ability to understand an interpret dimensional drawings.
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description.
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.

3rd Shift: Sunday-Thursday from 11:30PM - 8AM.

• Interacts with all departments pertaining to implementation of statistically established studies either for process improvements or establishment thereof.
• Ensure quality of all materials used in the process by developing and implementing effective reliable testing techniques.
• Ensure continued reliability of testing techniques by maintaining current knowledge of all technical and analytical information.
• Write technical reports as required to defend or support decisions concerning material acceptability.
• Establish and implement reliable procedures to ensure compliance with good manufacturing practices.
• 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.
• Support the efforts of production in materials related areas as a technical advisor.
• Reviews data using InTouch and eDart software, for investigation of problems.
• Take appropriate action to ensure compliance with all safety, health and hazardous communication standards.
• Ensures that established policies, rules and regulations, and procedures are followed.
• Actively participate and comply with all West HSE programs and regulations.
• Maintain a neat and orderly work environment in accordance with West 6S program.
• Other duties as assigned.

• Associate or Bachelor’s Degree or equivalent on the job experience in a technical discipline to include manufacturing, industrial, materials or plastics.

• Experience: 3-5 years of job-related experience
• Knowledge of the basic principles of injection molding, systematic molding, mold design, mold assembly, and machine operations.

• Must have excellent interpersonal & problem-solving skills & be able to interface with employees at all levels of the organization; must possess good organization, time-management, negotiating & conflict resolution skills.
• Must be familiar with computers and various software programs.
• Familiarity with SAP, Master Control or similar systems and databases, a plus.
• Knowledge of statistical tools and Minitab.

• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.

• Manufacturing\Six Sigma Green Belt Certification preferred

• While performing the duties of this job, the employee is regularly required to, sit, stand, walk, talk, hear, see and use hands and fingers to operate office equipment (ie phones, computers, copies, etc.).
• Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites.
• The ability to be able to lift and carry various items up to 40 pounds.
• The employee is occasionally exposed to wet and/or humid conditions and fumes or airborne particles.
• The employee occasionally works near moving mechanical parts and or equipment.
• The employee occasionally works in clean room environments requiring special gowning and training to operate in these environments.
• The noise level in the office work environment is usually quiet. The noise level in the manufacturing work environment is moderate to loud. Hearing protection is required as posted in the manufacturing work environment.
• Job requires mental skill or ability such as communication, decision making (sometimes quick), interpreting data, reading, or writing, organization, problem solving, understand direction, etc.

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

• 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 Engineering or another scientific area or equivalent experience required

• 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.

• Good knowledge of LEAN and 6 sigma manufacturing principles
• Knowledge of statistical tools and Minitab
• cGMP knowledge
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company's safety and quality policies at all times

• 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

• Determining product acceptability by performing various visual, functional and dimensional evaluations using various types of measurement devices such as micrometers, calipers, digital or dial indicators, comparators, force testers, and torque testers to determine product acceptability.
• Providing assistance in the development of sampling plans, as required.
• Basic understanding of Statistical terminology required to evaluate data and make a determination as to process capability; providing written summarization of study data to engineering or other groups as requested.
• Using Minitab software to create summarized data and graphs in support of engineering activities.
• Assisting in the training of manufacturing and support personnel in quality assurance related subjects.
• Performing internal quality audits as part of the internal audit team.
• Support new product development working with Engineering to perform dimensional and functional testing.
• Evaluating current processes for improvement opportunities.
• Performing in-process inspections in support of the manufacturing group.
• Ability to evaluate dimensional and functional test results to determine compliance to specifications.
• Performing calibration tasks for equipment and gauges in support of the Calibration Program.
• Performing raw material inspection and testing, as back –up to the Quality Assurance Inspector.
• Verify effectiveness of operator’s inspection process by performing selective product sampling audits.
• Other duties as assigned.

• High School Diploma preferred
• Preferred 2-year certification in Quality Assurance or commensurate training.

• No min required 1 to 3 years manufacturing experience required

• Demonstrate proficiency through literacy testing.
• Must be familiar with computers and various software programs such as Microsoft Word, Microsoft Excel. Master Control and Mattec a plus.
• Understanding of Statistical Process Control, blueprint reading and use of measuring/testing equipment.
• Must have excellent interpersonal & problem-solving skills & be able to interface with employees in all levels of the organization; must possess good organization, time-management, negotiating & conflict resolution skills; excellent computer skills (including MS Office experience using Word & Excel) required.
• Ability to understand an interpret dimensional drawings.
• 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

The Tooling Engineering Technician objective is to support the operations, tool room, and engineering departments to ensure plant meets company goals and objectives. In this role, you will be part of a team that relies on effective teamwork and global collaboration in a fast pace and dynamic environment. This role is responsible to manage key customer requirements, including preventative maintenance tracking, validated and unvalidated spare components, and validations of customer molds. Heavy communication directly with customer is required for this position.

• Maintain and support existing tooling.
• Participate in new mold design reviews.
• Monitor preventative maintenance schedules.
• Work with the local Tooling Engineers participating in factory acceptance trials and site acceptance trials.
• Support Process Engineers and technicians during initial mold sampling, trials and validation runs to document, troubleshoot and resolve problems as they arise.
• Support operations to resolve problems and issues as related to mold design and function as assigned.
• Maintain mold drawing system and update mold designs for internal ECN’s.
• Support process improvements, cost reductions/savings, scrap reductions, etc. through the implementation of LEAN concepts.
• Other duties as assigned.

• Education: Associate or Bachelor’s Degree in a technical discipline to include: mechanical engineering, manufacturing engineering, industrial, or plastics; or three to five years related experience and/or training; or equivalent combination of education and experience.

• No min required 3-5 years of relevant work experience required
• Prior manufacturing experience in an industrial setting (pharmaceutical industry experience preferred) required
• Experience with using SolidWorks and AutoCAD required

• Must have excellent organizational interpersonal and problem-solving skills and be able to interface with employees in all levels of the organization
• Excellent computer skills required including all MS Office applications
• Effective personal time management skills
• Ability to quickly adapt to changes in a dynamic environment
• Must be able to negotiate and effectively resolve conflicts when required
• Must be able to speak English fluently
• 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
• Able to comply with the company’s safety policy at all times

• Higher National Certificate in Engineering Discipline. Upon Hire preferred

• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• According to the principles of health and safety at work (substantiated by the Safety Leadership Statement), the job holder is aware of his/her particular responsibility regarding work safety and acts accordingly at all times
• The job holder is aware of his/her special responsibility for quality according to the company’s quality policy and conducts his/her activities in accordance with the company quality policy at all times.
• The job holder respects all specifications arising from the cGMP requirements and from the specifications DIN ISO 15378 and DIN EN ISO 9001 as per its current state and also as it applies to any future amendments. Support and contribute in Lean Sigma programs and activities towards delivery of the set target.
• 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

• Take a lead role in West’s early conceptual Injection Molding development process
• Use strong analytical skills to understand and implement customer/user needs, market requirements and other design inputs.
• 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.
• Lead the installation and validation of new equipment/process development through SAT/IQ/OQ/PQ.
• Translate product requirements into device specifications
• 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 writing validation documentation Provide project leadership for materials / process / Tooling related projects by coordinating the efforts of the various departmental disciplines for the successful completion according to plan and budget
• Create engineering change requests for modifications to equipment and the introduction of new equipment/molds
• Managing internal and external resources to meet the technical requirements of the project, such as outside vendors, and management of techs and/or interns
• Prepare detailed technical reports and design documentation in compliance with the Innovation Group’s internal development process

• Work with Industrial 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
• Managing of projects using good engineering principles and techniques
• Support the management of external engineering and design resources with appropriate interaction with their technical teams
• 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. Plastics required.

• Experience: 8-10 years of experience
• Regulatory compliance in cGMP manufacturing and testing of Pharmaceutical or Medical Device Products.

• Excellent written and verbal communication skills
• 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.
• Should have a good knowledge of the principles of WCM, JIT, SMED, and Kaizen
• 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
• 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
• 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