דרושים Maintenance Technician ב-West Pharma ב-ארהב

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

• 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.

• Maintains equipment and tools to ensure that they are available when needed and in good working condition; includes housekeeping, parts storage, equipment maintenance, ensuring calibration of equipment against specified standards, and tool using.
• Works with maintenance personnel including contractors working on specific projects, to ensure that they are performing their work efficiently in a safe, compliant manner.
• Performs minor electrical maintenance/repair to include, but not be limited to, replacement or repair of fixtures (e.g. wall switches and outlets, incandescent and fluorescent bulbs and tubes, ballast, sockets, fuses, minor appliances, cords, etc.) using appropriate hand, power, and specialty tools and determines when an electrician is required.
• Assists with departmental and employee moves. Disconnects computer equipment. Hangs pictures, shelving and televisions, as needed.
• Carryout preventative measures and look for alternative solutions to maintenance problems encountered
• Ability to learn basic hydraulic and pneumatic maintenance
• Work with operators to improve TPM/ PM program
• Follow directions and communicate effectively with all levels of plant personnel
• Weekly and monthly PMs - reporting and documenting
• Performs minor and major repair of all buildings and equipment on a routine basis.
• Ensures all equipment and facilities are cGMP compliant and are running efficiently and safely.
• Dismantles moves, assembles, and installs furniture, as needed. Transports goods or equipment, as assigned.

• Maintain and promote a safe and clean work environment throughout the maintenance department
• Instruct, train, guide and assist other maintenance personnel as needed.
• Performs other duties as assigned based on business needs.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance.

• High School Diploma or GED equivalent is Required.

• No min required maintenance and manufacturing experience preferred

• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, schedules, diagrams, and procedure manuals
• Ability to work weekends and overtime as required
• Experience in medical device industry or other regulated industry
• Able to apply basic concepts of algebra, geometry and trigonometry.

• Must be able to wear and use a full-face respirator
• Stand and walk for 12 hours per shift
• Willing to work overtime as needed
• Frequent bilateral grip/grasp and manual dexterity work required
• Frequent bending and twisting, squatting, pushing and pulling and working at elevated heights and in confined spaces as required by the job
• Must be able to tolerate industrial odors, heat and high temperatures, and smells on a frequent basis

Responsible for maintaining operation efficiency of automated assembly lines. Provide support to shift operations as request by the shift leader/production manager. Develop long-term predictive/preventative maintenance plans for all assembly equipment.

• Logically troubleshoots and repairs the pilot assembly line and related bench top equipment.
• Assists shift lead in maintaining quality of finished product through proper machine operation.
• Responsible for maintaining spare parts inventory with a proper cataloging of parts.
• Provide a timely notification to shift lead of maintenance issues and downtime.
• Reviews line history and documentation to enhance line efficiencies. Follows escalation plan to minimize downtime.
• Maintains and updates all equipment log books with accurate repair/adjustment information.
• Interfaces daily with shift leader and technician at shift change.
• Contributes to continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste.
• Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Maintains a clean, orderly and safe workstation and environment at all times.

• Conforms with and abides by all regulations, policies, work procedures, instruction, and safety rules.
• Exhibits regular, reliable, punctual and predictable attendance.
• Performs other duties as assigned based on business needs.

• High School Diploma or GED Required

• 1 year experince with troublshooting manufacturing machinary.

• 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.

• 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 be stressful due to competing resources while at all times maintaining company confidentiality.
• Must be able to work scheduled 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.

• Responsible for the maintenance of all process equipment on site and support Facilities and Utilities where required.
• Support commissioning/validation on existing and new projects.
• Lead the scheduled calibrations and maintenance as per Standard Operating Instructions.
• Track projects (task, activity, phase, resource loading, etc.) using project management software.
• Support in the management of maintenance contracts and contractors.
• Filing and archiving of Facilities and Maintenance documentation.
• Work with Engineering to identify maintenance strategy for all equipment.
• Ensure CMMS (computerized maintenance management system) users are fully trained and adhering to procedures.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Work to identify opportunities for improvements.
• Work with Maintenance Engineer and Quality Engineers to ensure PM program is kept up to date.
• Support investigations to close deviations, change control and CAPA’s.
• Responsible for compiling standard specifications and procedures for each item and monitoring all existing plant to standard specifications.
• Responsible to ensure minimum equipment downtime through preventative and corrective maintenance.
• Respond to failed equipment or out of spec to meet production/batch release requirements.
• Plan equipment downtime with production and external vendors.
• Assist in developing/reviewing/updating relevant SOP and SOI for instruments and on site to global and industry standards.
• Good verbal and written communication skills in English and Spanish.

• Associate's Degree or Trade qualification/certificate in Mechanical, Electronics, Instrumentation or Engineering is required.
• Bachelor's Degree in Electro Mechanics, Engineering, or related field is preferred.

• Minimum 3 years hands on working experience preferably in a maintenance role within the pharmaceutical/medical devices/manufacturing industry required.

• Familiarity using CMMS.
• Ability to interpret/design electrical schematics and to read hydraulic, pneumatic and PandID drawings
• Good knowledge of PLC Programming
• Previous experience working on technically challenging applications would be an advantage (i.e.) medical, tight tolerance work.
• Team player
• Strong competence in IT
• Excellent interpersonal skills with the ability to work with all levels within the organization.
• Structured way of working and strong organizational skills

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.

Management and implementation of facility projects and support in holistic building management. 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. Troubleshoot PLCs in a production. Other responsibilities include sourcing parts for obsolete 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 Engineering, QA, and Facilities in resolving problems, improvements, investigations etc. In this role you will service/maintain several machines, while learning the others in the department. 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.

• Complete preventative maintenance, clear lines, and perform die changes on all trim presses
• Perform PLC troubleshooting
• Ability to use a computer
• Provide emergency /unscheduled repairs to equipment as needed based on priorities provided
• Perform advanced mechanical, electrical, pneumatic and hydraulic repairs and installation
• Complete repairs of process and support equipment
• Provide guidance to team members
• Assist with designing and installing systems
• Housekeeping duties as necessary and applicable
• Perform simple Machinist Duties as needed
• Assist with writing and revising maintenance procedures and produce drawings and wiring diagrams
• Read and interpret manuals and workorders to perform required maintenance and service to diagnose problems, repair or replace parts
• Willingness to learn new equipment and processes as required
• Comply with safety procedures and maintain a clean work environment
• Perform other duties as required

• High School Diploma Or GED Required
  • Electrical Degree Preferred
  • Combination of advanced education or experince totaling 5+ years

• No min required required

• Experience with ISO 9000 standards and GMP’s
• Excellent communication and interpersonal skills.
• Agile working style
• Ability to work weekends and overtime as required

Management and implementation of facility projects and support in holistic building management. 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 obsolete 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 Engineering, QA, and Facilities in resolving problems, improvements, investigations etc. In this role you will service/maintain several machines, while learning the others in the department. 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.
• Respond to production maintenance request and any unscheduled down time.
• Troubleshoot and adjust or repair ancillary equipment like blow overs, bulb pullers, and heaters.
• Changeovers and setups on Vision Systems, make minor adjustments as required.
• Perform ink mixing as well as disposing of procedure as per set Safety/QS 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 obsolete 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 Continuous Improvement, Safety initiatives, audits, investigations etc.
• Support projects and improvement initiatives from engineering, process, QA, Safety and Operations groups.
• Document performed tasks for the day into the maintenance log before the end of each 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.
• Implementation and collaboration of facility projects

• High School Diploma Or GED required

• 3 years manufacturing maintenance experience

• Experience with plastic injection molding preferred.
• Experience with robots and pick in place robots.
• Experience with ISO 9000 standards and GMP’s.
• Excellent communication and interpersonal skills.
• Experience with SAP or similar software for maintenance tracking.
• Agile working style.
• Ability to work weekends and overtime as required