דרושים Design Engineer Global Tooling & Product M/f/d ב-West Pharma ב-גרמניה

• Program Activities:
• • Responsible for ensuring proprietary design & development projects are executed in compliance with relevant regulations; regulatory requirements; international standards; and enterprise and local procedures.
  • Identify and support the use of improved quality practices by R&D teams during design control activities; and facilitate the smooth integration of quality requirements into design processes.
  • Report on the progress of projects; identify successes; and drive compliance.
  • Escalate quality-related issues to the Design & Quality Assurance Director or designee, as required.
  • Review and approve relevant design history file documents; product drawings; component specifications; labelling; procedures.
  • Support design transfer activities for commercial and launch readiness and sustainment.
• Verification and Validation Activities:
  • Review and approve test method validations (protocols and reports).
  • Review and approve design verification and design / process validation documents (e.g. protocols & technical reports).
  • Facilitate and support the completion of projects up to and including PQ.
• Risk Management Activities:
  • Responsible for authoring and/or reviewing and approving Risk Management Plans, risk assessments and Risk Management Summary Reports for proprietary design & development projects.
  • Facilitate and/or participate in risk assessment meetings with proprietary design & development teams.
• QMS Activities:
  • Support enterprise procedures updates that impact design and development activities.
  • Drive the closure of change controls and protocol non-conformance reports (PNRs).
  • Review and draft relevant procedures and forms for the management of activities connected with product design & development.
  • Act as the interface between development teams and operational quality:
  • Perform first article component and product inspections
  • Draft defect libraries and quality inspection documents during OQ; and manage formal hand over of same to Operational Quality prior to PQ.
  • Support the supplier selection process in accordance with West supplier management procedures.
  • Conduct and support internal and supplier audits, as required.
  • Lead internal audits of R&D and support site QA in the preparation and hosting of third party and customer audits.
  • Lead and manage QMS activities including CAPAs, Failure Investigations, Non-Conformance assessments, audit findings, issue reviews, document control, change controls, and configuration management. Provide direction on non-conformances, deviations, or excursions and drive to closure.
  • Actively engage in robust problem-solving to address quality issues.
• Metrology Activities:
  • Review and approve metrology data during OQ & PQ.
  • Support Quality Function Deployment activities (QFD).
• Compliance to all enterprise and local company policies and procedures.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all site Environmental, Health and Safety requirements, training, and regulations.
• Perform additional duties at the request of the direct supervisor.

• Bachelor's Degree in Chemistry, Engineering or Quality discipline required

• 5 years working in a high-volume manufacturing environment, ideally in the Medical Device / Pharmaceutical sectors.

• Desirable: Regulatory Affairs experience

• Must have practical experience working with design teams and providing design assurance support according to international regulatory requirements.
• Working knowledge of ISO 13485, ISO 9001, ISO 15378 and 21 CFR Part 820 is essential
• Work experience in the life science industry or another highly regulated, international environment would be considered an advantage
• Experience in Project Management
• Experience in process technology, by preference with elastomers.
• Risk Management experience within design and development with good working knowledge of ISO 14971.
• An excellent understanding of rubber and plastic manufacturing technologies, analytical methods and testing.
• Knowledge of analytical tools and methods, including statistics (Minitab preferred).
• Must be able to organise and prioritise tasks.
• Must have critical reading skills, maintain a high attention to detail and overall quality of work.
• Must be self-motivated, able to prioritize and multi-task, work independently and make sound judgements, work under time constraints, thrive in face-paced environments.
• Strong problem-solving skills, including root cause failure analysis methods.
• Must have excellent written and verbal communication skills.

• ISO 13485/9001/15378 Auditor or Lead Auditor Training / Certification upon hire is preferred.

• Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• Excellent written and oral communication and interpersonal abilities, with the capacity to communicate complex technical concepts to diverse stakeholders.
• Ability to work independently, multi-task and thrive in fast-paced environment.
• Strong problem-solving skills including root cause failure analysis methods.
• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
• Must maintain the ability to work well with others in a variety of situations.
• Critical reading skills and maintain high attention to detail, accuracy, and overall quality of work.
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Ability to make independent and sound judgments.
• Observe and interpret situations, analyze and solve problems.

Number of Direct Reports:Approximately 16
Contract Terms:Full-time, fixed term
asap

• Disciplinary and operational management of the shift as well as further development of employees
• Workforce planning and machine allocation
• Implementation of an open communication culture
• Monitoring and implementation of standards on topics such as quality, GMP, lean, regulations, documentation, and KPIs
• Production or processing of materials
• Supplying machines with raw materials
• Conducting a proper shift handover
• Involvement in projects (e.g., introduction of new technologies)
• Training and support of (new) employees

• Successfully completed vocational training

• Professional experience in a production environment, preferably in the pharmaceutical sector
• Leadership experience

• Good knowledge of SAP and MS Office
• Fluent German skills, both spoken and written; English skills are advantageous
• Successfully completed Lean and Six Sigma training (Yellow Belt) or willingness to complete the training
• Strong sense of safety, quality, and responsibility
• Structured planning and independent, goal-oriented working style
• High commitment and willingness to drive change
• Ability to work on shifts (3-shift system)

In this role, you are responsible for the planning, implementation, and monitoring of the Energy Management System (EnMS) for West Germany. The aim is to increase energy efficiency, reduce energy costs, and meet legal requirements in line with ISO 50001. You will coordinate the energy team and manage tasks related to energy management.

• Management, monitoring, maintenance, and continuous improvement of the EnMS, including all meters
• Analyzing and monitoring energy consumption to identify trends and savings potentials, and preparing the energy assessment
• Informing and training employees about energy management and energy savings, including the creation of training materials
• Regular reporting on the results of measures and progress in achieving energy goals
• Ensuring compliance with relevant energy laws and standards (50001)
• Planning and accompanying internal and external audits of the energy management system
• Identifying and monitoring energy efficiency measures and the use of new technologies for energy savings
• Monthly updates and the creation and archiving of the annual energy report

• Successfully completed degree or diploma in Mechanical Engineering, Electrical Engineering, Environmental Engineering, or a similar field

• Several years of professional experience in energy management and ISO 50001

• Strong knowledge of MS Office
• Good command of English, both written and spoken
• Excellent communication, cooperation, and teamwork skills
• Strong organizational and planning skills as well as analytical and decision-making abilities

• Contract Terms: Part-time, Fixed-term for 1 year
• Start Date: Immediately

• Support the Process Engineering department
• Manual data collection and analysis of production data
• Development of automated dashboards for production control
• Support in the implementation of AI-driven analyses
• Visual inspection and evaluation of production trials
• Statistical evaluations using MS Office/Minitab or similar

• Advanced studies in Engineering (Mechanical, Electrical, Chemical or a comparable field)

• Strong technical understanding and quick comprehension
• Proficient in MS Office
• Knowledge of VBA, databases, etc., is desirable
• Good command of English, both spoken and written
• Structured and systematic work approach
• High level of teamwork and communication skills

In this role, you will provide Quality Management System best practices across the programs you support. This role ensures regulatory and quality compliance and is responsible for planning, scheduling, executing and communicating all items regarding quality issues, complaints, validations and other projects in support of Customer Program Operations and product release. You may ensure suppliers deliver products which comply with requirements and specifications. You may lead efforts to enhance the supply chain by addressing supplier and customer issues, improving quality processes internally and with suppliers. You take on responsibilities in customer and supplier communication and actively implement West's quality policy at the Stolberg site.

• Investigation and processing of customer and supplier complaints
• Leading departmental projects for lean work structures
• Supporting internal and cross-factory projects
• Initiating and following quality-relevant processes in local Deviation and CAPA Management
• Conducting customer and supplier audits and processing related reports
• Implementing measures from audit processes with internal and external stakeholders
• Supporting factory functions in root cause analysis and implementation of corrective actions
• Managing relevant change processes according to West Change Control Policy
• Assisting in local training within the framework of quality initiatives
• Assisting in the creation of summaries and statistics for management
• Meet company and departmental goals in the continuous improvement of all products, services and processes, including the West QMS.
• Other duties as assigned

• Bachelor's Degree in Engineering or Science or equivalent experience required

• Minimum 5 years of professional experience in quality or a quality-related interface
• Proficiency in standard project management tools and software (e.g. Microsoft Project, Excel) for planning, tracking, and reporting project activities, and proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point required

• Proven knowledge in DIN ISO 9001:2015
• Very good MS Office and SAP skills
• Excellent German and English skills, both spoken and written
• Proficient use of statistical analysis tools (e.g., Minitab)
• Strong awareness of safety and organizational talent
• High teamwork capability and ability to act independently
• Strong problem-solving skills and project management experience
• Knowledge in DIN ISO 15378:2017 and Six Sigma Green Belt training are desirable

• Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• Excellent written and oral communication and interpersonal abilities, with the capacity to communicate complex technical concepts to diverse stakeholders.
• Ability to work independently, multi-task and thrive in fast-paced environment.
• Strong problem-solving skills including root cause failure analysis methods.
• Critical reading skills and maintain high attention to detail, accuracy, and overall quality of work.
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.