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Fresenius Kabi

Global provider of therapies and devices

Lead Reliability Technician

Inspection & TestConfirmed live in the last 24 hours
Full-timeWarrendale, PA, USA$30 - $32 /hrIn-person

About the Job

Requirements

  • A high school diploma or equivalent and advanced vocational training, specialized technical certification, or equivalent technical education are required.
  • At least 5 years of related laboratory, test, manufacturing, service, or medical-device experience, including extensive experience independently performing multiple technical processes, resolving difficult non-routine issues, and supporting daily technical operations.
  • Advanced knowledge of laboratory equipment, operational procedures, test methods, Microsoft Word, Microsoft Excel, and applicable quality-system requirements, with demonstrated expertise sufficient to serve as a recognized technical resource for laboratory operations, test execution, validation activities, and difficult non-routine issues.
  • Familiarity with applicable Test Method Validation (TMV) processes, including supporting documented validation activities for test methods, fixtures, and measurement or data-collection systems.
  • Ability to independently plan, coordinate, and complete complex technical assignments under limited supervision, including non-routine situations and process exceptions.
  • Ability to recognize patterns, analyze difficult non-routine product or test behavior, select and adapt established procedures within authorized limits, and escalate matters requiring engineering judgment or additional authority.
  • Demonstrated ability to troubleshoot complex equipment and test-system issues, coordinate service or setup activities, and maintain laboratory readiness.
  • Ability to coordinate daily priorities, interact with cross-functional stakeholders at various levels, and explain technical findings.
  • Ability to train lower-level technicians, delegate daily technical tasks, verify delegated work against established procedures, and escalate discrepancies without formal hiring, firing, or performance-management authority.

Responsibilities

  • Use Microsoft Word and Excel to create, review, maintain, and oversee complete and accurate test records in applicable electronic systems and folders.
  • Configure and coordinate complex test samples, equipment, fixtures, and data-collection systems; collaborate with engineering to help design, build, implement, refine, and support validation of test fixtures as needed; apply applicable Test Method Validation (TMV) processes; and verify that test setups meet protocol, safety, quality-system, and laboratory requirements.
  • Independently manage the full scope of Field Return intake and evaluation activities, including difficult or non-routine process exceptions, and coordinate escalation of significant findings.
  • Support failure investigations by collecting and evaluating evidence, reviewing logs, performing product teardown, and documenting likely failure conditions and preliminary conclusions for engineering review.
  • Execute and coordinate reliability test protocols under limited supervision, including non-routine situations requiring planning, preparation, analysis, and selection or adaptation of established procedures within authorized limits.
  • Select and adapt established procedures as appropriate for assigned work; escalate situations requiring procedural approval, engineering judgment, or authority beyond the role.
  • Accurately document test results, observations, defects, investigation evidence, process exceptions, and preliminary conclusions in approved systems and templates.
  • Oversee maintenance, verification, troubleshooting, and readiness of reliability test equipment; coordinate service, installation, setup, dismantling, and assembly activities as required.
  • Analyze and resolve difficult, non-routine product, test-setup, and equipment issues that follow recognizable patterns; communicate findings and escalate complex issues requiring engineering review.
  • Lead and remain accountable for daily technical operations within assigned laboratory activities; establish and coordinate work priorities, validation activities, equipment availability, service needs, and laboratory readiness; serve as the primary technical coordination point for assigned work; verify that activities are completed safely and in accordance with established procedures; and escalate staffing, performance, or priority conflicts to management.
  • Communicate test status, process exceptions, technical issues, investigation findings, and results to engineering personnel, customers when applicable, and cross-functional stakeholders at various levels.
  • Identify and recommend practical improvements to test execution, equipment setup, or laboratory organization and support implementation after appropriate approval.
  • Train lower-level technicians, delegate daily technical tasks within approved work plans, verify that delegated work conforms to established procedures, and escalate discrepancies, technical questions, or workload conflicts as appropriate.
  • Ensure compliance with company documents and programs related to Health, Safety, Environment, Energy, and Quality Management Systems in accordance with assigned roles and responsibilities.

Desired Qualifications

  • An associate degree.

About the Company

Fresenius Kabi

Global provider of therapies and devices

Fresenius Kabi is a global healthcare company that provides medicines, medical devices, and services for the treatment of critically and chronically ill patients. Its portfolio includes biosimilars for autoimmune diseases and cancer, clinical nutrition products, infusion pumps and related disposables, blood collection bags and devices, and IV generics and fluids. It stands out with leading market positions in areas like blood collection and infusion materials and offers an integrated mix of pharma, nutrition, and MedTech offerings under the FutureFresenius strategy. Its goal is to shape the future of healthcare by expanding its global therapies and technologies, improving patient care, and delivering sustainable value for stakeholders.

Company size
10,001+
Company stage
Not listed
Total funding
Not listed
Headquarters
Bad Homburg, Germany
Founded
1999

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