Supervisor, Metrology
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About the role
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. Technical (Product and Process) Oversight over the functional testing areas supporting combination product testing. Ensure alignment between metrology systems and functional testing requirements to support accurate and reliable product evaluation. Own and govern the site-wide calibration and metrology program, ensuring traceability to national/international standards (e.g., NIST), compliance with GMP/ISO requirements, and alignment with internal procedures. Execute and support metrology activities, including calibration, verification, and troubleshooting of measurement systems to ensure accuracy, reliability, and compliance. Supervise internal and external contractors involved in calibration and metrology activities to ensure they are compliant with PCI procedures and industry standards. Ensure calibrations are performed, documented, and maintained in a compliant and timely manner, including review of calibration records for accuracy and traceability. Develop, implement, and improve measurement methods and techniques to support product inspection, functional testing, and process validation activities. Design and execute Measurement System Analysis (MSA) activities (e.g., Gage R&R, bias, linearity, stability) to ensure measurement systems are fit for intended use. Develop, standardize, and implement metrology best practices across the site, ensuring consistency in measurement techniques, calibration approaches, and equipment usage. Collaborate internally to create a 'One PCI' standardized approach for testing processes, standards, training, and test execution at the Philadelphia site as well as other PCI locations. Direct oversight of the metrology testing center to include the execution of safety, quality, delivery, and cost objectives, along with employee engagement. Develop and provide tracking tools, metrics, and visual management for planning commercial and research testing capacity against performance standards. Manage the equipment, process, and sample management activities of the work area. Support a work environment characterized by employee involvement and participative management to encourage the highest level of employee commitment and cooperation. Provide technical support for issues arising on the production floor, utilizing work instructions, design documents, and specifications. Ensures continuous compliance of functional testing equipment. Develop and implement new test methods for functional testing equipment (e.g., Instron, Zwick) to support new customer programs, product introductions, and technology transfers. Support and maintain existing test methods, ensuring alignment with customer requirements, technical specifications, and validated state. Provide technical oversight for functional testing activities, including test execution, data analysis, and troubleshooting of equipment or method-related issues. Participates in budget planning process based on revenue targets and financial goals, inclusive of consumables, instrumentation, and resourcing needs. Identifies opportunities for cost savings. Ensures timely and appropriate resolution of CAPA and quality incidents, quality and compliance metrics, root cause analysis and improvement. Responsible for the development and tracking of key functional metrics. Stay current with new technical developments and support implementation of new tests, equipment, programs, and procedures. Support and lead continuous improvement initiatives within the metrology function, including optimization of calibration processes, reduction of measurement variability, and implementation of improved measurement technologies. Ensure appropriate development and maintenance of SOPs for instrumentation/metrology. Serves as a subject matter expert (SME) in metrology, supporting investigations, deviations, validations, audits, and regulatory inspections. Support the creation and delivery of training programs on metrology practices, instrumentation, and functional testing methods. May guide other facilities on equipment and instrumentation queries. Responsible for supporting six sigma, quality, and safety initiatives. Collaborate cross-functionally (Quality, Validation, Engineering, Operations) to ensure metrology requirements are properly defined and implemented for new equipment, processes, and products. Interface directly with customers to support technical discussions related to metrology and functional testing, inclu