Engineering Lab Manager, R&D

West Pharmaceutical Services-posted about 1 month ago
Full-time • Manager
Onsite • Scottsdale, AZ
5,001-10,000 employees
Miscellaneous Manufacturing
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Responsible for collaborating with global customers and internal stakeholders, executing a scalable strategy to provide labopratory testing support and services to development and sustainment of West's proprietary drug delivery systems. Lead the laboratory team in the areas of test method development & validation, equipment management, device testing, and data analysis. Responsible for the management and reporting of all insights and data for all applicable projects and programs. Communicate at all levels of the organization and be responsible for identifying and engaging key stakeholders and cross-functional resources throughout the process.

  • Direct management over the R&D laboratory operations and laboratory staff (technicians and engineers) that support the testing and analysis of drug delivery systems, including daily project planning, scheduling and resource planning.
  • Accountable for meeting lab performance metrics related to quality of work and on-time delivery.
  • Ensures all lab spaces are equipped with the necessary equipment, tooling, and furniture required for performing the lab's designated function in a safe and effective manner.
  • Leads the lab team in solving complex technical challenges. Demonstrations a high level technical competency. Ensures the appropriate analysis techniques, analysis results, and graphical outputs are generated by the lab.
  • Oversees and guides the development of test methods, as well as the planning and coordination of test method validations/Gage R&Rs. Ensures all engineering test fixtures, assembly fixtures, test methods, assembly methods have gone through the appropriate level of Gage R&R and Qualification throughout the development process.
  • Responsible for managing laboratory access and laboratory safety. Ensures lab personnel comply with the company's safety and quality policy at all times.
  • Responsible for the creation, maintenance, and adherence to laboratory processes and procedures to ensure compliance with global WEST Quality Management System (QMS), OSHA, local, state and federal environmental regulations.
  • Collaborates and coordinates with other global lab managers on harmonizing lab software systems, equipment, procedures, and processes.
  • Recognizes inefficiencies and takes initiative to improve processes and implement procedures to streamline workflows and increase effectiveness.
  • Plans, coordinates, and executes on lab renovation/expansion projects; including authoring Project Expenditure Requests, generating POs, coordinating with external vendors, and overseeing all aspects of the project; inclusive of facility infrastructure changes, purchase & installation/qualification of new equipment, employee training, and implementing safety policy and procedures.
  • Works closely with R&D platform leaders and program directors to assure adherence to the product development and testing timelines. Participates in the development of project scope and timelines for lab-related elements of new Development Agreements (DAs).
  • Assists manager with annual strategic planning goals and budget planning forecasts.
  • Responsibile for hiring, training, developing, mentoring and growing the laboratory team to meet their individual and professional goals while fulfilling current and future business needs.
  • Ensures compliance with Good Laboratory Practices (GLP) and Good Documentation Practices (GDP).
  • Exhibits regular, reliable, punctual and predictable attendance.
  • Demonstrates a "Customer Service" attitude when interacting with internal and external customers.
  • Bachelor's Degree Engineering or equivalent experience required
  • Experience in a lab setting required
  • Minimum 8 years Related experience required
  • Leadership and mentorship qualities to provide training and guidance to staff.
  • Excellent communication and interpersonal skills.
  • Excellent problem-solving skills as well as keen analytical abilities.
  • Excellent technical writing skills.
  • Exhibit regular, reliable, punctual and predictable attendance.
  • Demonstrate a "Customer Service" attitude when interacting with internal and external customers.
  • Expertise in lab safety and general lab work practices.
  • Expertise in laboratory testing of electromechanical devices, specifically medical devices in accordance with FDA regulations.
  • Expertise in test method development and validation of medical devices.
  • Knowledge of ISO 13485 - Quality Management Systems for Medical Devices.
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