דרושים Quality Technician - Shift Role Ftc ב-West Pharma ב-Ireland, Dublin

In this role you will be responsible for performing Supplier Quality activities associated with external suppliers. This role performs activities to ensure West supplier’s maintain compliance with West’s procedures and policies. You will interface with R&D, Sourcing, Design Quality, Regulatory and Operations Quality to drive improved supplier quality performance.

• Establish and successfully executesupplier management planswhich will align to overall business objectives

• Maintain a strong collaborativepartnership

• supplier performanceincluding incoming failures, manufacturing yields and field failures to drive Supplier Corrective Action Reports (SCARs)

• ExecuteSupplier Corrective Action Requests(SCAR) with suppliers, ensuring effective and timely closure

• Work with suppliers, R&D, and Sourcing on continuous improvement of supplier performance includingsupplier changerequest.

• Evaluate potential new or future suppliers and support supplierselection processwith the cross-functional team

• Participate in cross-functional teams of design engineering and quality engineering to work with suppliers duringproduct developmentand ensures agreement for manufacturable, cost-effective designs

• Approves components for use in products by drivingProduct Approvalactivities with the suppliers

• Supports Supplier evaluation,auditmanagement and related records

• Supports the evaluation and development ofQuality Agreements and purchasing specificationswith suppliers

• Support the development of anIncoming Inspection strategyon purchased products

• Bachelor's Degree In Engineering or Science required
• Master's Degree In Engineering or Science preferred

• Bachelor’s degree in engineering or related science

• Minimum 5 years of quality related experience with preferred experience in pharmaceutical and/or medical device industry

• Experience working with suppliers and supplier engagement activities

• Knowledge of sterilization process is preferred

• Knowledge of cGMP, cGDP, relevant ISO standards, medical device requirements and other international regulations

• Familiarity with MasterControl, SAP and working knowledge of statistical data analysis

• Fluent in English

• Thorough understanding of validation activities and risk management principles and techniques

• Strong problem-solving and critical thinking skills

• Negotiation skills and collaborating with suppliers

• Ability to work under high volume production and fast changing environment

• Willingness to work in a cross-functional team with different time zones

• Able to comply with the company’s safety policy at all times.

Supports manufacturing projects and contributes to the development and implementation of the business manufacturing strategy. Responsible for the implementation of manufacturing solutions to meet the requirements of customers’ product introductions. Reports directly to the Senior Automation Engineer.

• Support equipment process and product introduction projects
• Work on the implementation of the manufacturing strategy to meet customer and Tech Group Europe needs.
• Participate in project teams, identifying deliverables, time and cost, setting priorities and reporting to meet the needs of the business and the customer.
• Supports Tech Group Europe’s relationships with the customers and equipment suppliers in pursuit of new business, product development, manufacturing process development, continuous improvement and on-going business development.
• Work with equipment suppliers ensuring delivery meets specification, cost and time.
• Ensure that equipment meets the regulatory requirements of the business. Validation, health and safety etc.
• Support the installation of equipment with appropriate training and hand over to operations
• Work with all departments across the business to ensure that processes meet their requirements.
• Identify, specify and introduce manufacturing methods and opportunities into the company
• Assist with the training and development of personnel in Tech Group Europe on processes or systems introduced to the company.
• Ensure that the procedures and systems are in place to facilitate the introduction of processes and equipment.
• Carry out maintenance of equipment where needed
• 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.
• Compliance to all local site company policies, procedures and corporate policies.
• Perform additional duties at the request of the direct supervisor.

• Minimum Level 6 in engineering discipline

• Minimum 2 years Experience in medical device industry or other regulated industry required
• Minimum 2 years Experience in supporting technical project management preferred

• Must have knowledge in computer systems, word processing and spreadsheets, and ideally in integrated manufacturing systems, Allen Bradley & Siemens PLC’s,Motion and Machine Control Systems.
• Must have knowledge of Robotics, Cognex Vision Systems, Barcode Scanning & RFID Automatic Identification and Data Capture used in High Volume Manufacturing.
• Preferably have a knowledge of Industrial Networks (Ethernet IP,Control Net & Profibus) and has worked on an MES system. Must have a good understanding of Manufacturing Automation, and ideally in Machine design, Development and Validation Process.
• Preferably worked in either the Medical, Packaging or technological industries with a good understanding of the regulatory requirements.
• Must have good written and verbal communication skills as well as the ability to accurately document work performed.
• Must be able to work in a fast paced environment.
• Must be able to travel as required by the position.
• Must be able to organize and prioritize tasks; must be detail orientated and self-motivated.
• Must be able to work independently on own projects while working concurrently with all departments and levels of employees.
• Knowledge of quality systems requirements, FDA Quality System Regulation, cGMP and relevant ISO standards

• This is a 4 cycle 24/7 shift role.

Please Note this role is a 12 month FTC

• Assist with ­­the development and implementation of recruitment plans
• Source, screen and assess qualified candidates for targeted job requisitions
• Build and maintain a pipeline of qualified and diverse talent
• Collaborate with key stakeholders and HR partners to understand the business needs and ideal candidate profiles to deliver effectively on the hiring needs of the business
• Help to meet hiring needs through planning of job fairs, interview days, or other high-volume candidate processing programs
• Establish and build relationships with other recruiters and HR team to share knowledge, HR trends and experiences to execute best practices enterprise wide
• Provide data, research and analysis on competitive intelligence, labor trends, information about external marketplace and West’s employer brand position to attract top talent
• Manage all activities within the West applicant tracking system (ATS) and accurately track and report recruitment activity data to support staffing metrics from the time a requisition is opened to the time candidates are identified for offer and onboarded
• Participate in special projects and perform other duties as assigned based on business needs
• Abide by all regulations, policies, work procedures, instruction, and all safety rules

• Bachelor's Degree or equivalent experience in Business or Human Resources discipline required

• Minimum 3 years of recruiting experience in an agency, search firm or corporate setting required

• Ability to multitask in a high-pressure environment
• Demonstrated success developing relationships and meeting new people
• Strong administrative and computer skills including Microsoft Office, applicant tracking systems and social media channels
• Ability to prioritize work and manage deliverables and timelines independently
• Knowledge of sourcing techniques using a variety of sourcing tools and platforms

Manages the maintenance and repair of equipment in operation at West. Liaises with external contractors for the maintenance and repair of same. The Maintenance Technician is also responsible for using the preventative maintenance system to pre-determined guidelines. Reporting directly to the Maintenance Supervisor.

Please note - This position is a FTC until June 26

• Responsible for the maintenance and breakdown repair of moulding equipment (including among others, moulding machines, automation/robots, water heaters, oil heaters, conveyors, and hot runner controllers).
• Work with the Production Managers to troubleshoot equipment/plant problems.
• Establishes relationships with the customers and suppliers in pursuit of continuous improvement and on-going business development.
• Attends, schedules, and facilitates internal meetings to help establish priorities and assign tasks
• Solves, in conjunction with the Quality department, customer related problems/issues as needed
• In conjunction with approved vendors, research new processes and/or systems for maintenance/manufacture of equipment and implement new processes and systems as developed under the direction of the Operations Manager.
• Instructs others, formally or informally, regarding manufacturing related skills or knowledge and assist in the training of employees on new processes or systems introduced to the company
• Compliance to all site Environmental, Health and Safety requirements, training, and regulations
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Perform additional duties at the request of the direct manager

• Associate's Degree Time served QQI Level 6 Advanced Certificate Craft – Electrical required
• Bachelor's Degree Engineering preferred

• Minimum 3 years Minimum 2 years experience is required in troubleshooting various manufacturing equipment. required

• Sound knowledge of CMMS and MS Office
• Any other certifications are a plus.
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Able to always comply with the company’s safety policy.
• Able to always comply with the company’s quality policy.
• Knowledge of PLC Programming and electrical work
• Ability to read electrical, mechanical, and hydraulic/pneumatic drawings is essential
• Ability to interact with suppliers, customers, and external contractors

• Must be able to lift 35 lbs. continuously and up to 75 lbs. occasionally, with or without assistance.

Note: This is a Fixed-Term Contract

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 obsoleted 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, QA and Facilities in resolving problems, improvements, investigations etc. In this role you will Service/maintain several machines, while learning the others in the departmet. 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
• Troubleshoot and adjust or repair ancillary equipment like Blow overs, Bulb pullers, Heater
• Changeovers and setups on Vision Systems, make minor adjustments as required
• Perform ink mixing as well as disposing of procedure as per set Safety/QA 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 obsoleted 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 CI, Safety initiatives, Audits, investigations etc.
• Support projects and improvement initiatives from engineering, process, QA, Safety and operations group
• Document performed tasks for the day into the maintenance log, before the end of the 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

• High School Diploma or equivalent preferred

• No min required required

• Basic understanding of machine operability and mechanical assemblies.
• Read and interpret basic electrical, mechanical, pneumatic and hydraulic schematics.
• Available for overtime, self-starter, a team player and should be able to work independently.

Note: This is a
12 month fixed term contract.

In this role, you will be responsible for developing new technology and supporting existing technology to improve production, quality, profitability and safety. This individual will be responsible for the planning, scheduling, execution of projects and communicating project status to targeted timelines. This individual will also manage/assist in facility expansion/modifications.

• Support development of new technology, existing technology and existing production lines to improve quality, profitability and safety.
• Develop, execute and document project assignments in compliance with committed timelines and project goals, and per established governance policies and procedures.
• Ensure technical and customer requirements for assigned projects are achieved.
• Develop and maintain required validation and project management documents.
• Conduct or participate in routine project reviews with Project Teams and Management
• Perform design work, layouts, sketches, concepts, etc. as needed for projects and/or plant layouts.
• Develop and/or review engineering change requests for modifications to processes, equipment and facilities.
• Troubleshoot and repair of all automation.
• Evaluate and maintain proper machine safeties to ensure employees are protected when operating any piece of automation.
• Ensure automation lines are meeting their targeted output and OEE by analyzing production data.
• Maintain quality finished product through proper maintenance and operation of all automation.
• Provide timely notification to shift leaders and program managers of maintenance and down time issues.
• Interfaces daily with engineering manager and shift support staff.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Performs other duties as assigned by management.
• Exhibits regular, reliable, punctual and predictable attendance.
• Automation includes – assembly machines/fixtures, label applicators, robots, end of arms, separators and test equipment. Any other equipment assigned by management.

• Associate's Degree In a relevant Engineering subject required or
• Bachelor's Degree In a relevant Engineering subject preferred

• Minimum 3 years Experience in medical device industry or other regulated industry required
• Minimum 3 years Experience in supporting technical project management preferred

• Background in medical devices/pharmaceutical would be a plus.
• Knowledge of quality systems requirements, FDA Quality System Regulation, cGMP and relevant ISO standards

• Must be able to work a 40-hour work week, plus overtime and/or irregular hours as required to complete assignments. May stand or sit for extended periods of time. Must transport oneself to and from other areas of the facility and travel to other divisions when necessary. Must have good visual acuity. If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues.
• Medical Device manufacturing requires strict adherence to standards. Working environment is a manufacturing facility, which houses plastic injection molding machines. Must tolerate fumes and particulate generated from various plastics. Work areas are equipped with adequate lighting, cooling/heating and equipment that are in a good working condition. Must work constructively in an environment that may always be stressful due to competing resources while maintaining company confidentiality.