Engineering Technician jobs at West Pharma in United States, Tempe

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.

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

Help installation, maintenance, and repair workers in maintenance, parts replacement, industrial machinery, and electrical and electronic equipment. Perform duties such as furnishing tools, materials, and supplies to other workers; cleaning work area, machines, and tools; and holding materials or tools for other workers.

• 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 OEM Techs, 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, plumbing, house keeping duties 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 required

• 2 years of Manufacturing Maintenance Experience.

• 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 8 hours per shift
• Willing to work overtime as needed
• On call weekends
• 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

• Provide leadership defining the strategy in support of long-term and intermediate goals within Global Process Development in collaboration within the Global Contract Manufacturing and Technology Network.
• 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.
• Use strong analytical skills to understand and implement customer/user needs, market requirements and other design inputs.
• Support CM Sales team in all new business quoting and gathering customer requirements relating to Process Engineering requirements.
• Identify, execute, and implement process improvement initiatives across the Global platform.
• Provide leadership/guidance on the installation and validation of new equipment/process development through SAT/IQ/OQ/PQ.
• Ensure that the procedures and systems are in place to facilitate the introduction of new processes and equipment.
• 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 preparing technical documentation/presentations. 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
• Managing internal and external resources to meet the technical requirements of the project, such as outside vendors, and management of techs and/or interns
• Work with Tooling 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
• 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 or another scientific area or equivalent experience required. Preferred Plastics
• Master's Degree in Engineering or another scientific area preferred

• Minimum 8 years in a similar position within the manufacturing industry required
• 3 years` experience in leading multifunctional teams of professionals globally required
• Good knowledge of LEAN and 6 sigma manufacturing principles (Green belt) required
• Good know-how and experience in Project management required
• Regulatory compliance in cGMP manufacturing and testing of Pharmaceutical or Medical Device Products.
• Ability to manage projects, teams, maintain timelines, and execute projects in a Global Engineering environment

• Expertise in injection molding techniques, methodology, and trouble-shooting methods; a deep understanding of equipment, process, and tools relating to injection molding
• Must have excellent written and verbal communication skills as well as the ability to accurately document work performed.
• 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.
• 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
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• 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
• 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

• Lead the site Manufacturing/Project Engineering Department to ensure full alignment with the company and site strategies which includes significant growth utilizing new and existing technologies.
• Improves manufacturing engineering and management job knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies.
• Develops strategic manufacturing operations plan by evaluating marketing and product objectives; calculating equipment, process, and labor capacity and requirements; determining tooling and maintenance objectives and requirements; developing layouts; establishing priorities.
• Manage and coordinate plant and capital projects, properly document work, and maintain history of projects in appropriate project files.
• Propose and lead equipment and process improvement initiatives to improve operating performance
• Create strategic plans to eliminate waste within the business by utilizing lean process, best practices and enterprise resource management.
• Provide engineering guidance to assure plant, machinery, and processes are optimized. Set up or participates in continuous improvement teams related to establishing a process or process improvement.
• Maintain ownership of assigned equipment, or business processes.
• Collaborate and interface with internal and external global teams and Subject Matter Experts (SMEs) as needed to maintain relationships and global process alignment.
• Lead/support validation activities including equipment validation and process validation. Improve processes and procedures to manufacture a quality product at a minimum cost. Provide technical expertise to other plant personnel.
• Research and analyze data such a vendor design proposal, specifications, and manuals to determine feasibility of design or application.
• Assist in installation of new products, tooling and related processes; investigate tooling and process problems; make new product/process recommendations.
• Provides engineering assistance to ensure plant, machinery, tooling and processes are at optimum.
• Continuous coaching of team members and assist with developing/implementing team member growth plans.
• Participates in Design for Manufacturing (DFM) reviews with internal teams. Reviews drawings, 3D models, and specifications to facilitate manufacturability.
• Improves cost effectiveness by studying operations; designing and conducting improvement studies.
• Provides manufacturing engineering information and reports by collecting, analyzing, and summarizing manufacturing engineering data and trends.

• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Proven ability to effectively prioritize and execute tasks in a high-pressure environment
• Must also be able to maintain confidentiality and resolve conflicts.
• Make independent and sound judgments.
• Multitask, work under time constraints, problem solve, and prioritize.
• Excellent communicator with ability to maintain confidentiality and resolve conflicts and ambiguity.
• Use written and verbal communication skills effectively.
• Read and interpret data, information and documents to analyze and solve problems.
• Learn and apply new information and new skills.
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times.

• Bachelor's Degree in Engineering or a related field required or
• Master's Degree in Engineering or a related field preferred

• Minimum 10 years Experience in a technical engineering role or related areas including direct experience in equipment design, procurement, FAT, SAT, and IQ/OQ. required and
• experience in pharmaceutical/biotech manufacturing, or medical device manufacturing environment. required and
• Direct knowledge and experience in project management within a biopharmaceutical or pharmaceutical cGMP environment. preferred

• Excellent written and verbal communication skills with all levels of employees. Must exhibit a positive and professional upbeat tone and manner.
• High proficiency for problem solving in teams and as an individual contributor. Exceptional verbal and technical writing skills; ability to provide focus and clarity. Independently motivated, detail oriented and good problem-solving ability.
• Excellent organizational skills with the ability to multi-task in an extremely fast-paced environment with changing priorities.
• Knowledge of Computer Aid Design such as AutoCAD or Solid Works.
• Strong essential skills including high emotional intelligence
• High sense for the business; strong business acumen
• Strong coordination and Project Management skills
• Engages others, builds relationships, and creates networks outside team. Checks in with different people to understand the bigger picture.
• Ability to perform root cause analysis and corrective action solutions. Follows through on actions.
• Is curious, agile, engages in new experiences and looks for different perspectives

• Program and Project Management\Certified Project Management Professional (PMP)-PMI Upon Hire preferred and
• Manufacturing\Lean Six Sigma Black Belt within 1 Year required

• Comfortable working in a manufacturing environment.
• Specific vision abilities may be needed by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
• Make independent and sound judgments.

• Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• Provide Quality oversight and direction for Quality Engineers.
• Provide direct supervision, resolves personnel issues, conducts performance evaluations and performs supervisory discipline as necessary.
• Recommend, evaluate, and implement process changes that are designed to continually improve the quality management system.
• Provide quality oversight, author, review, and/or approve site documentation (validation, change control, SOPs, WKIs, etc).
• Lead and manage QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, audit findings, issue reviews, etc. Provide leadership and direct input on any nonconformance, deviation, or excursion that may occur and drive to closure.
• Direct involvement with FDA and ISO inspections and any external audits/assessments to ensure that the facility Quality Management System is properly represented. May act as lead for ISO and customer audits.
• Interface with customers for quality issues, technical information, specification, agreements, audits, etc.
• Recruit, train, develop, and lead staff to accomplish personal and organizational goals, adhere to policies/procedures and establish/maintain a ‘culture of quality’.

• Bachelor's Degree in Engineering or Science required and
• Chemistry or Engineering Degree preferred and
• Graduate degree preferred

• Minimum 8 years Minimum 8-10 years of experience required and
• Relevant work history and/or experience may be considered in lieu of degree and/or years of experience required and
• Previous experience with MasterControl, SAP, Share Point, Teamcenter preferred and
• Experience with ISO 13485 and 21CFR Part 820, 210, and/or 211 preferred

• Preferred previous experience with Master Control, SAP, SharePoint, Teamcenter
• Experience using Six Sigma and SPC tools and techniques
• Ability to use Excel, Word programs
• Must be able to operate and maintain office equipment (i.e. copy machines, multi-media, etc.).
• 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.

• Engineering - General\ASQ Certified Quality Engineer (CQE or CQA) Upon Hire preferred and
• Manufacturing\Six Sigma Green Belt Certification Upon Hire preferred or
• Manufacturing\Lean Six Sigma Black Belt Upon Hire preferred

• 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
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems
• Effectively communicate and interface with various levels internally and with customers