Supervisor, Metrology

PCI Pharma Services•Philadelphia, PA

14h•Onsite

About The Position

PCI Pharma Services is seeking a Supervisor, Metrology to oversee and govern the site-wide calibration and metrology program. This role is critical for ensuring traceability to national/international standards (e.g., NIST), compliance with GMP/ISO requirements, and alignment with internal procedures, particularly for combination product testing. The supervisor will execute and support metrology activities, including calibration, verification, and troubleshooting of measurement systems, and supervise internal and external contractors. Key responsibilities include developing and improving measurement methods, designing and executing Measurement System Analysis (MSA), and implementing metrology best practices. The position also involves direct oversight of the metrology testing center, managing equipment, processes, and samples, and providing technical support for production issues. The supervisor will develop and implement new test methods for functional testing equipment, participate in budget planning, and ensure timely resolution of CAPA and quality incidents. This role requires staying current with technical developments, leading continuous improvement initiatives, and serving as a subject matter expert (SME) in metrology. Collaboration with cross-functional teams and direct interaction with customers on technical discussions and audits are also essential. The supervisor will also be responsible for supplier ownership, maintaining testing equipment, and providing technical leadership and mentorship within the organization.

Requirements

Bachelor’s degree in engineering or related field.
At least 5-7 years of experience in drug delivery devices, medical devices, or combination products.
Core understanding of metrology practices within a regulated industry.
Prior supervisory experience as a front line leader.
Demonstrated proficiency with personal computers, business software (e.g., MS Office) and technical software (ERP and eQMS systems).
Ability to create, use and interpret scientific tables, charts, and graphs.
Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
Analytical ability to drive effective Root Cause Analysis (RCA) and critical thinking for complex problem solving.
Prior experience in technical writing and utilizing root cause analysis tools is required.
Critical thinking skills along with a strong collaborative approach is required.

Nice To Haves

ASQ or similar Certified Calibration Technician (CCT), Lean Six Sigma Certification, ASQ Certified Quality Engineer (CQE), or similar certifications are highly desirable.
Possesses excellent organizational, time management and multi-tasking skills to meet commitments and deadlines.

Responsibilities

Provide 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.
Participate in budget planning process based on revenue targets and financial goals, inclusive of consumables, instrumentation, and resourcing needs.
Identify opportunities for cost savings.
Ensure 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.
Serve 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, including test methods, measurement systems, and data evaluation approaches.
Support customer audits, visits, and technical reviews, providing clear and defensible explanations of testing methodologies, measurement systems, and compliance controls.
Perform additional duties as specified by management.
Maintain all testing equipment and assets throughout their useful lifecycle to include procurement; qualification; operation, calibration and maintenance.
Develop relationships with functional testing and metrology equipment vendors to ensure ongoing technical support, maintenance, and lifecycle management.
Work with instrument and equipment suppliers to develop appropriate service level agreements, onsite technical visits, upgrades and costing over an asset’s useful life.
Work with quality to qualify new and audit existing suppliers as needed.
Collaborate with the engineering, commercial operations, procurement and ancillary groups and wider development, manufacturing, and procurement teams for high priority product-program initiatives.
Provide technical leadership and mentorship in metrology principles, measurement science, and best practices across the organization.
Mentor staff on metrology practices, including proper use of measurement equipment, calibration requirements, data integrity expectations, and good documentation practices.
Demonstrate attention to detail and self-motivation to deliver work to the highest standards.
Demonstrate multitasking, planning work, scheduling tasks, coordinating activities, and managing time efficiently.
Demonstrate timely problem-solving using data driven tools and methods.
Present quality standards, process flows, inspection plans, and/or issues both internally to stakeholders and externally to clients with confidence and accuracy.
Attend work as an essential function of this position.