Reporting to the Director of Process Validation, this Senior Process Validation Engineer (System Integration) will provide leadership and expertise in the validation of assay systems for the state-of-the-art clinical laboratory.
The successful candidate will play an influential and leading role in ensuring that the assay systems and processes are installed, operate, and perform as specified; and capable of reliably and repeatedly producing products of the required quality. This position will also partner closely with Engineering and Quality Assurance to pilot new assay system processes that are compliant with the applicable regulations and standards. He/she will apply and advocate best practices in system integration and assay verification and validation, train the appropriate team members and identify opportunities for continuous improvement.
RESPONSIBILITIES / DUTIES:
Lead assay systems verification and validation in the clinical laboratory.
Develop strategies for system-level integration and testing; including assay reagents, consumables, hardware, and software.
Author, review and/or approve validation documentation (Validation Plans, Risk Assessments, Specifications, Protocols and Reports, Trace Matrices) and change controls for compliance with applicable business and regulatory requirements.
Support the development of user requirements, system requirements, system architecture and design, risk analysis, and usability engineering for new assay system introduction or process improvement.
Make data-driven decisions by designing experiments and collecting, analyzing, and presenting data results.
Enforce Good Documentation Practice (GDP) and Data Integrity.
Develop and communicate expectations for quality performance, continuous improvement, process controls infrastructure for critical sustaining parts and new products.
Operate a variety of laboratory instrumentation and simulators to perform assay system integration and functionality testing with new software and hardware.
Participate as the assay system Subject Matter Expert during internal and external audits/inspections.
Train others in the configuration, deployment, use and/or maintenance of assay system workflows.
Contribute to cross-functional efforts that ensure compliance with ISO13485, ISO15189, ISO 62304, and other domestic and international regulations and standards.
A BS degree in engineering or science (preferably in bioengineering, biomedical engineering, chemical engineering, computer science, information systems, software engineering or a closely-related discipline) and a minimum of 8 years of related experience. An MS with at least 5 years or a Ph.D. with at least 3 years of related work experience will also be considered.
Minimum 3+ years of experience in assay system verification and validation in a regulated environment (medical devices/IVD or pharmaceuticals).
Knowledge of assay system design control and validation, particularly those related to automated laboratory instruments, in compliance with ISO13485, ISO 62304, ISO15389 or other similar standards.
Experience with standard molecular biology techniques for purification, quantitation, and amplification of nucleic acids.
Able to apply risk-based approach to testing strategies, for a more efficient and targeted validation effort.
GDP and data integrity enforcement experience.
Demonstrated ability to lead cross-functional teams through the design, testing, and implementation of automation workflows.
Experience partnering with Development and Quality Assurance to build compliant workflows, processes, and procedures.
Demonstrate Systems Engineering best practices.
Skilled in identifying root cause and complex problem-solving.
Excellent interpersonal, written, and verbal communication skills.
Ability to work as part of a cross-functional team according to an established timeline.
Experience programming automated laboratory instruments and/or systems, such as liquid handling robotics.
Five or more years of experience working in medical devices/IVD.
Knowledge of TECAN EVOWare and/or Hamilton Venus scripting language.
Familiarity with CAP and/or CLIA regulations.
Project management skills or certification.