דרושים Manufacturing Engineer ב-West Pharma

In this role, you will be responsible to handle raw materials acceptance activities, NCM reports related to raw materials, write and update procedures and forms related to incoming inspection.

• Responsible for raw materials acceptance activities in ERP/SAP, including approval of acceptance records generated by incoming inspectors and issuance of Certificate of Compliance for approved raw material.
• Responsible to verify that all acceptance test results follow GMP and GDP guidelines
• Responsible for handling of all related incoming inspection non-conforming materials (NCM), including performing root cause analysis, generate corrective actions and leading MRB meetings to determine the materials disposition.
• Responsible to write Special inspection /Rework instruction related to incoming inspection process
• Responsible to write and update incoming inspection Forms and procedures
• Responsible for the approval of all graphic and label related raw material.
• Responsible for the approval of Line clearance performed by quality inspectors

• Education- Technical/ Practical Eng.
• At least 2 years of relevant experience in Quality in the Medical Device/pharma industry
• Courses related to Medical Device regulation- an advantage
• Knowledge with ERP/ SAP- an advantage

• At least 2 years of relevant experience in Quality in the Medical Device/pharma industry

• Ability to work under pressure
• Good interrelation skills
• Technical ability- ability to read technical drawings
• Creativity
• High Learning ability
• Organized
• Ability to prioritize
• Excel -basic knowledge and experience.
• Written and verbal communication skills: Hebrew- Mother tongue . English- Good

• 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
• Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception and the ability to adjust focus.
• Ability to perform basic mathematical tasks like counting, adding, subtracting, and rounding and to record, balance and check for accuracy.
• Effectively communicate and interface with various levels internally and with customers

Additionally, this role will identify and implement improvements to the production processes.

The Manufacturing Quality Engineer will be the products and production focal point for our sub-contractors and will be responsible for projects related to the production and machines, including training, audits, stop and renew the production.

• Exhibit a strong “quality first” mentality and ensure that product and quality are held to the highest standard.
• Meet company and departmental goals in the continuous improvement of all products, services and processes.
• Work cross-functionally with individuals or extended teams to provide guidance and ensure success of projects
• Responsible to write, review and approve pilot documents (including reports).
• write and approve various department and production procedures and forms.
• Lead investigation processes for deviations and nonconformities in production and create analysis reports.
• Responsible to train the sub-contractors according QA procedures and VoE.
• Supports special processes such as sorting or rework in production.
• Own on all production activities at one of the subcontractors to ensure manufacturing is held according to West procedures and GMP/GDP standards
• Responsible for stopping and renewing production with accordance to West requirements and with MQ manager approval.
• Manage production relates projects and act as MQ focal point in various internal and external projects- such as Data Integrity, CoPQ, production improvement plans, etc.
• Provide Quality oversight of validation activities and processes.
• Lead pilot processes which include change and approval of quality aspects in pilot protocols and reports and assure that pilot processes are conducted according to West guidance and protocols.
• Attend production pilot meetings as the MQ focal point.

B.Sc. in Science or Engineering

• 3years of experience in Medical Device Quality & Productionifecycle
• Relevant work history and/or experience may be considered in lieu of degree
• Experience with production processes and process controls
• Experience with sub contractors interface and meeting customer expectations
• Experience with Medical Device, Validation Activities, Risk Management, Product Transferto production
• Working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971, MDSAP
• Must have effective problem solving and interpersonal skills
• Ability to work independently, multi-task and thrive in fast-paced environment
• Problem solving including root cause failure analysis methods

• Previous experience with MasterControl, Share Point, Teamcenter- a plus
• 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
• 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
• Observe and interpret situations, analyze and solve problems
• Effectively communicate and interface with various levels internally and with customers
• Certified auditor- a plus
• Relevant work history and/or experience may be considered in lieu of degree

• 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.
• Self-motivated with the ability to make independent and sound judgments.
• Read and interpret data, information, and documents
• Learn and apply new information or skills

In this role, you will be involved in Engineering procedures and activities, such as leading Lean Manufacturing processes, Engineering documentation Management, NPI projects and more.

• Knowledge transfer and updating from R&D to Production Floor, for new products, new manufacturing process, new equipment, machines and injection molds.
• Lean Manufacturing, Productivity and process, products cost reduction.
• Leading large scale global and cross organizational projects.
• Supporting West Pharma IL manufacturing, quality control and Regulatory activities (machines related product and malfunctions analysis and repair).
• Sustain engineering support for all production processes (Machines and Molds Maintenance, repairs, spare- parts and enhancements).
• Tooling and production processes enhancements (Molds, Automations, Jigs and Fixtures- design and built).
• Product Engineering Industrialize and Scale- up to mass production- projects managements (machines characterizations, Projects Follow- Ups: DR's, Acceptance tests, installations, Qualifications- Verification and Validations).
• Tech Office Management- (Documentations, Revisions, part and Product Specifications, Drawings and SOPs).
• Equipment and process qualifications/ enhancements for West Pharma IL production lines.
• Developments of products configurations.
• Molds Tracing and supervision.
• Product Support engineer at production floor.

• Education: B.Sc. Mechanical Engineering / B.Sc in a different field with a background in Manufacturing processes, Process development, project management etc.
• Experience: at least 5 years in similar roles.
• Fluent in Hebrew and English: Writing/ Reading/ Speaking.

• Ability to work under pressure.
• Excellent Interpersonal relation.
• Ability to work independently self-direct.
• Analytical problem-solving skills.
• Proven Technical experience and knowledge.
• Creativity.
• Excellence learning skills.
• Excellent organizational skills including the ability to efficiently evaluate, prioritize and handle multiple and changing projects.
• Experience with Windows office and Solid works
• Able to comply with the company’s safety
• Able to comply with the company’s quality policy at all times
• Relevant work history and/or experience may be considered in lieu of degree

• 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

• Update programs to support current productions systems as well as work with teams to develop and create complete solutions to implement new systems.
• Use engineering principles to design configurations and develop parameters for programmable/configurable devices to implement enhancements to the operation of equipment.
• Create or modify pneumatic, hydraulic, mechanical, and/or electrical systems to support new or current manufacturing systems as well as create or update all supporting drawings and documentation.
• Analyze data to identify opportunities to create new systems which support the advancement of manufacturing operations.
• Manage projects by creating teams and utilizing techniques and processes throughout the entire project lifecycle: Initiating, Planning, Executing, Monitoring/Controlling, and Closing.
• Write or approve all necessary documentation to design, purchase, install and maintain new equipment and systems. For example, user specifications, request for quotes, design requirements, functional requirements, functional procedures, acceptance and validation protocols.
• Train team members on functional procedures and troubleshooting techniques to support and maintain equipment and systems.
• Lead activates with maintenance, engineering, and vendors to create, install, and validate new equipment and systems.
• Assist corporate and other facilities as needed to troubleshoot complex problems or support standardized equipment and systems.
• Any other duties as required.

• Bachelor's Degree related field required

• Minimum 5 years related work experience required and
• previous experience in a manufacturing working environment and/or industrial setting required and
• experience with Project Management processes and techniques preferred

• Proficient in AutoCAD and Microsoft Office based programs including Project and Visio.
• Knowledge of terminal services for remote support of equipment and systems.
• Have a functional understanding of cGMPs
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times

• 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