Engineering Technician Product Analysis jobs at West Pharma in United States, Scottsdale

In this role, you will be under the direction of the Product Analysis Manager to support activities related to product root-cause failure investigations on electro-mechanical drug delivery devices in a biohazard laboratory. You will additionally drive investigation process lean initiatives, manage communication with internal and external customers, train team members on new devices and assist with coordinating work for the lab technicians.

• Receive, log, and organize all incoming packages, ensuring proper documentation and maintaining order throughout the entire complaint workflow process
• Maintains processes and procedures for receiving handling, storage, and disposition of returned devices according to regulations and company standards.
• Maintains the product analysis lab including supplies, calibration, equipment maintenance, safety adherence, capacity improvements, and access
• Coordinate lean process improvements for device investigations, lab procedures, and daily productivity as needed.
• Communicates with customers regarding product issues and returned devices.
• Creates and maintains a clean, neat, and safe work environment through identifying and resolving potential safety hazards.
• Promotes teamwork and collaboration between departments to optimize processes and resolve problems.
• Monitor upcoming deadlines and ensure all tasks are assigned and completed on time.
• Demonstrates a “Customer Service” approach to all activities and assignments.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Complies with the company’s safety and quality policies at all times, including proper handling of biohazard materials and components.
• Exhibits regular, reliable, punctual and predictable attendance.
• Complies with site and enterprise safety procedures when handling biohazard materials/components and potent drug compounds.

• 0 - 3 years of experience required
• Experience working in a laboratory or cGMP/pharmaceutical environment preferred
• Laboratory administrative/Coordinator/Analyst role preferred

• Experience in conducting root cause investigations of field units.
• Experience in laboratory test equipment operation and maintenance such as Instron, CT scanner, oscilloscope, power supply, multi-meter, and microscopes.
• Background in Microsoft excel for the purposes of trending complaint data.
• Background in medical device or pharmaceutical industry.
• Knowledge of lean manufacturing and operational excellence concepts.
• Able to comply with the company’s safety policy at all times.

• Must be able to stand for long periods of time
• Use hands to finger, handle, feel or operate objects, tools or controls and reach with hands and arms
• Physical ability and willingness to wear proper gowning for work in an ISO 5 compliant particulate cleanroom environment
• 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 follow directions, 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

• Direct mechanical engineers in design activities including ideation, prototyping, performance testing & analysis, design selection, requirement setting, and change requests.
• Develop and drive drug delivery device mechanical engineering strategy and identification of key capabilities needed for scale and growth.
• Provide technical oversight of team outputs including mechanical systems models, CAD models, 2-D dimensioned drawings, tolerance analyses, feature function maps, and mechanical dFMEAs.
• Develop and drive team to maintain and improve on team key performance indicators including schedule adherence, complaint & non-conformance reduction, and on target to budgeted spend.
• Interface with customers and external support services, e.g. suppliers and contract vendors, to facilitate the development and execution of assigned programs, as well as the development of technical services capability and capacity to meet future R&D needs.
• Select, develop, and manage global technical team ranging from early career to senior manager level to meet current and future needs.
• Build and maintain strong relationships with customers, business partners, functional leaders, and other senior level executives.
• Support platform product development and sustainment strategy including product and process improvement roadmaps.
• Participate in industry forums and standards committees as a West representative.
• Perform other duties as assigned based on business needs.
• Conform with and abide by all regulations, policies, work procedures, instruction, and all safety rules.

• Bachelor's degree in Engineering or othertechnical related field, or equivalent experience required
• Master's degree in Business Administration or Engineering preferred

• Minimum 10 years of experience in mechanical design or engineering capacity required
• Minimum 3 years experience in a leadership role required.

• Demonstrated ability to:
  • Lead, prioritize, and complete multiple technical projects and daily tasks.
  • Lead and mentor others.
  • Facilitate and coach others through effective problem solving and decision making processes.
  • Understand and communicate technical ideas and concepts with technical and non-technical audiences (written and verbal).
  • Delegate and empower others while maintaining accountability to overall functional performance.
  • Work well with others in a variety of situations.
• 5+ years of medical device and/or drug delivery system product development experience.
• Background in development or sustainment of electromechanical products.
• Broad experience in product development from early feasibility through commercialization and into sustainment including design controls, statistics, test method development, gauge R&R, human factors engineering, design verification, and design validation.
• Proficiency in GD&T, tolerance analysis methods, and finite elemental analysis (FEA).
• Proficiency in SolidWorks, CETOL, SAP ECTR, MS Office Suite, Minitab, and DevOps.
• Experience influencing business and technical teams to adopt alternative ideas and methods.
• Knowledge of injection molding industry and respective processes

In this role, you will be responsible for performing testing of products for internal and external customers using a variety of analytical techniques. You may be assisting in developing procedures for instrumentation, test instructions, and test reports. You may coordinate the day-to-day receipt and shipment of samples in the laboratory and support the Laboratory team in administration and quality systems.

• Perform analysis using various established or experimental techniques, instrumentation, and/or test methods while following standard operating proceedures (SOPs).
• Uses critical thinking skills to analyze field failures to identify the root cause and documents findings per procedures. Is familiar with and utilizes a variety of root cause analysis methodologies to assess technical problems.
• Uses software tools (Salesforce, MasterControl, Microsoft Office Suite) to document and manage investigations.
• With guidance, assist in completing projects from protocol to final report.
• Uses strong technical writing skills to communicate findings in a technical, concise, and effective manner.
• Train new analysts as appropriate.
• Exercises creativity in developing new test / debugging methods.
• Keep current with new analytical techniques and technology.
• Assist in preparation of technical reports, work instructions, SOPs, qualification documentation, lab study design and preparation in study plans and protocols.
• Apply internal QA procedures and perform lab investigations, OOS, and OOT as required.
• Actively participate in and complete all appropriate training tasks in a timely manner and meet individual and departmental goals as required.
• Work independently and collaboratively with other technical experts, and laboratory management, making rational and sound decisions with self-motivation, adaptability, and a positive attitude.
• Support laboratory management in data quality-documentation, and archiving.
• Maintain compliance to cGMP and ISO requirements and established safety procedures.
• May utilize various inputs to schedule work, use Sharepoint, SAP, Excel files, and Word documents. Proficiently use MS Office products for data gathering, reporting, and data entry.
• May handle Test Requests – write, review, and approve, and maintain traceability of samples.

• Bachelor's Degree in Biology, Chemistry or a relevant scientific field preferred
• High School Diploma required

• 0 - 3 years of experience required
• Experience working in a laboratory or cGMP/pharmaceutical environment preferred
• Laboratory administrative/Coordinator/Analyst role preferred

• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Knowledge of one of these skills: Container Closure Integrity, Physical / Mechanical testing such as Instron / Zwick, Particle Testing (HIAC, particle isolation, filtration and microscopy), Dimensional analysis (Smartscope or optical comparators)
• Method development and validation
• Willingness to learn and apply new analytical techniques
• Proficient in Microsoft Office tools and capable to learn other software programs
• Able to review regulatory code and learn safety standards
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety and quality policies at all times

• Must be able to stand for long periods of time
• Use hands to finger, handle, feel or operate objects, tools or controls and reach with hands and arms
• Physical ability and willingness to wear proper gowning for work in an ISO 5 compliant particulate cleanroom environment
• 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 follow directions, 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

• Responsible for the development and execution of sterilization strategies to ensure medical devices meet functionality and design standards.
• Perform risk assessments and validation studies to ensure the effectiveness and safety of sterilization methods and protocols.
• Develop, maintain, and update sterilization processes in compliance with industry standards and regulatory requirements.
• Work with R&D, Quality Engineering, and other departments to ensure product integrity during product introductions, sustaining changes, and transfers.
• Offer technical support and insight regarding sterilization processes and regulations to internal and external stakeholders.
• Analyze and monitor data to identify trends, driving improvements in sterilization processes.
• Identify, investigate, and resolve issues related to sterilization equipment and processes efficiently.
• Participate in audits to ensure compliance with regulatory standards, providing recommendations for continuous improvement.
• Train and mentor R&D teams on sterilization processes, procedures, and regulatory requirements.
• Oversee the commissioning, maintenance, and validation of sterilization equipment to meet operational and energy efficiency standards.
• Identify and drive process improvements initiatives and cost-saving opportunities related to sterilization systems.
• Manage regulatory filings and respond to inquiries from regulatory bodies concerning sterilization processes.
• Deliver progress reports and presentations to communicate activities and timelines to management and core team members.
• Adhere to West compliance and safety policies and procedures at all times.
  

• Bachelor's in Microbiology, Biomedical Engineering, or Chemical Engineering or related engineering disciplines required
• Masters Degree in related field preferred

• 5+ years of experience in development of sterilization, medical devices, or pharmaceuticals.
• Experience with CAPAs handling, Non-conformance, Deviations, Complaints handling (Product Evaluations Reports, Notifications to Competent Authorities) required.
• Experience leading sterilization development workstreams from concept through commercialization.
• Experience in working under requirements of Quality Management System in a regulated environment.
• Must have effective problem-solving abilities.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Able to comply with the company’s safety policy at all times.

In this on-site role, you will be responsible for performing testing of products for internal and external customers using a variety of analytical techniques. You may be assisting in developing procedures for instrumentation, test instructions, and test reports. You may coordinate the day-to-day receipt and shipment of samples in the laboratory and support the Laboratory team in administration and quality systems.

• Perform analysis using various established or experimental techniques, instrumentation, and/or test methods while following standard operating proceedures (SOPs).
• Uses critical thinking skills to analyze field failures to identify the root cause and documents findings per procedures. Is familiar with and utilizes a variety of root cause analysis methodologies to assess technical problems.
• Uses software tools (Salesforce, MasterControl, Microsoft Office Suite) to document and manage investigations.
• With guidance, assist in completing projects from protocol to final report.
• Uses strong technical writing skills to communicate findings in a technical, concise, and effective manner.
• Train new analysts as appropriate.
• Exercises creativity in developing new test / debugging methods.
• Keep current with new analytical techniques and technology.
• Assist in preparation of technical reports, work instructions, SOPs, qualification documentation, lab study design and preparation in study plans and protocols.
• Apply internal QA procedures and perform lab investigations, OOS, and OOT as required.
• Actively participate in and complete all appropriate training tasks in a timely manner and meet individual and departmental goals as required.
• Work independently and collaboratively with other technical experts, and laboratory management, making rational and sound decisions with self-motivation, adaptability, and a positive attitude.
• Support laboratory management in data quality-documentation, and archiving.
• Maintain compliance to cGMP and ISO requirements and established safety procedures.
• May utilize various inputs to schedule work, use Sharepoint, SAP, Excel files, and Word documents. Proficiently use MS Office products for data gathering, reporting, and data entry.
• May handle Test Requests – write, review, and approve, and maintain traceability of samples.

• Bachelor's Degree in Biology, Chemistry or a relevant scientific field preferred
• High School Diploma required

• No min required 0 - 3 years of experience required and
• Experience working in a laboratory or cGMP/pharmaceutical environment preferred
• Laboratory administrative/Coordinator/Analyst role preferred

• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Knowledge of one of these skills: Container Closure Integrity, Physical / Mechanical testing such as Instron / Zwick, Particle Testing (HIAC, particle isolation, filtration and microscopy), Dimensional analysis (Smartscope or optical comparators)
• Method development and validation
• Willingness to learn and apply new analytical techniques
• Proficient in Microsoft Office tools and capable to learn other software programs
• Able to review regulatory code and learn safety standards
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety and quality policies at all times

• Must be able to stand for long periods of time
• Use hands to finger, handle, feel or operate objects, tools or controls and reach with hands and arms
• Physical ability and willingness to wear proper gowning for work in an ISO 5 compliant particulate cleanroom environment
• 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 follow directions, 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

In this role, the R&D Laboratory Technician will work under the direction of the R&D Lab Supervisor to support the R&D lab team with test sample builds, engineering and design verification testing activities, and have responsibilities associated with lab management, inventory management, and equipment qualifications. The individual will bring excellent analytical, technical, and organizational talent to the execution of development projects at West.

• Performs and documents engineering and verification testing activities for a product (or product family).
• Proficient in laboratory test equipment operation and accustomed to using current Good Documentation Practices (GDP).
• Assists the engineering team in the development of test methods, work instructions, and other documentation as required.
• Prepares test samples according to work instructions and procedures for engineering and verification testing.
• Follows protocols required for Engineering Testing, Design Verification Testing, Test Method Validation, and Equipment Qualification.
• Participates in the execution of Gage R&R and qualification of engineering test fixtures, assembly fixtures, test methods, and assembly methods used in the development process.
• Manages component inventory for test samples. Performs incoming inspection and receiving activities for new inventory lot creation. Creates necessary documentation in support of assigned activities in compliance with West QMS
• Manages the calibration status of laboratory tools and equipment, communicates with calibration vendors to get equipment calibrated, reviews calibration certificates, and ensures proper storage of all associated calibration documentation.
• Performs regularly scheduled general preventative maintenance activities on laboratory tools, equipment, and machinery.
• Identifies and resolves potential safety hazards. Maintains a clean, neat, and safe work environment.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Performs other duties as assigned based on business needs.

• Technical experience performing testing in medical device industry.
• Uses critical thinking to make decisions and operate independently with minimal manager supervision.
• Highly organized person whom demonstrates initiative and commitment to quality in all tasks.
• Proficient in MS Office suite including PowerPoint, Word, Excel and Outlook.
• Excellent oral and written communication skills.

• High School Diploma required.
• Associate's Degree Technical Field (Chemistry/Biology/Engineering) preferred

• Experience: 3+ years of experience in a laboratory environment.

• Must be able to work assigned shift(s) with overtime as required to complete assignments if necessary.
• Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites.
• Potential handling of biohazard material and components.
• Provide a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.

In this role, you will work under the direction of the Complaints Quality Manager to support activities related to product root-cause failure investigations on electro-mechanical drug delivery devices in a biohazard laboratory. You will additionally drive lean initiatives on the investigation process, manage communication with internal and external customers, and train team members on new devices.

• Is proficient in the use and maintenance of laboratory test equipment necessary for conducting root-cause investigations; such as Instron, CT scanner, oscilloscope, power supply, multi-meter, microscopes.

• Is proficient in the process of conducting root cause investigations of R&D or returned field units.

• Utilizes on the job experience, critical thinking skills, and root cause analysis methodologies to assist lab technicians with atypical and/or complex root cause determination.

• Has effective technical writing skills and is able to communicate findings in a technical, concise, and effective manner with little to no assistance. Documents investigations reports per procedures.

• Assists the Complaints Quality Manager with:

  • Review and approval of investigation reports

  • Training technicians on the investigation processes and use of laboratory equipment.

  • Performing daily, weekly, and/or monthly tracking and trending activities related to complaints and other lab metrics.

  • New customer onboarding

  • Complaint-handling process improvements / lean initiatives.

• Contributes to the design and development of new tests and debugging methods.

• Identifies critical product issues. Assists with Issue Reviews and Corrective & Preventive Actions (CAPAs) when necessary. Contacts appropriate support and/or management to ensure issues are reported and resolved.

• Creates and maintains a clean, neat, and safe work environment through identifying and resolving potential safety hazards.

• Facilitates teamwork and collaboration between departments to maximize processes and resolve problems.

• Demonstrates a “Customer Service” approach to all activities and assignments.

• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.

• Complies with the company’s safety and quality policies at all times; including proper handling of biohazard materials and components.

• Exhibits regular, reliable, punctual and predictable attendance.

• Education: Bachelor's in Science or Engineering

• Experience: 3-5 years of experience

• Experience in conducting root cause investigations of field units.
• Experience in laboratory test equipment operation and maintenance such as Instron, CT scanner, oscilloscope, power supply, multi-meter, and microscopes.
• Background in medical device or pharmaceutical industry.
• Knowledge of lean manufacturing and operational excellence concepts.

• Demonstrated ability to:
  • Prioritize and complete multiple tasks. Has effective time management skills and can easily adapt to changes in priorities; needs little to no assistance in determining priorities and deliverables.
  • Understand and communicate technical ideas and concepts with technical and non-technical audiences (writtenand verbal)