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GxP Systems Engineer

ZifoNorwood, Massachusetts, United States
On-site Full-time

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Experience Level

Experience

Qualifications

The ideal candidate will be passionate about quality, continuous improvement, and system enhancement to ensure optimal user experience and operational efficiency. You should thrive in a dynamic work environment, willing to take initiative to define processes where none exist, and demonstrate strong collaborative abilities among a team of expert peers.

About the job

Location: Norwood, MA and Marlborough, MA

Zifo is actively seeking a dedicated GxP Systems Engineer to play a pivotal role in the validation, deployment, and administration of GxP laboratory benchtop computerized systems and enterprise systems. This position involves authoring and executing test protocols while ensuring compliance and enhancing system performance.

Key Responsibilities:

  • Collaborate closely with internal and external business analysts and software/automation engineers throughout the complete product lifecycle of various QC computerized lab benchtop systems (such as HIAC, FTIR, TOC, Bioanalyzers, Sequencers) and enterprise instrumentation systems (including Chromeleon Chromatography Data System, Scientific Data Management System (LogiLab), CFR Gateway (LogiLab), SoftMax Pro, etc.). Responsibilities will encompass system optimizations, compliance enhancements, support, maintenance updates, and version upgrades.
  • Interpret and translate system/equipment/data integration requirements from various Digital and Business teams to facilitate the deployment of appropriate Digital Lab System solutions.
  • Lead system validation activities in collaboration with Business, IT, Equipment, Validation, and QA partners to implement new systems, manage system life cycle upgrades, and address incidents through necessary fixes.
  • Independently author/update and approve lifecycle documents, including system impact assessments, regulatory applicability, criticality assessments, ERES assessments, URS, FRS, System Configuration/Design Specifications, and System Administration SOPs, while executing test scripts in accordance with cGxP standards.
  • Provide administrative support to QC labs for both Benchtop and Enterprise computer systems.
  • Act as a subject matter expert to investigate and resolve incidents requiring troubleshooting.
  • Generate periodic reviews, system audit trail reviews, and user access reviews for systems, assisting in periodic evaluations conducted by other SMEs.
  • Guarantee GMP compliance in the design, delivery, and maintenance of all systems.
  • Maintain inspection readiness through strict adherence to internal quality policies, procedures, and training.

About Zifo

Zifo is a leader in providing independent regulatory compliance and laboratory automation solutions tailored to the needs of the life sciences industry. Our commitment to quality and innovation ensures that our clients receive unparalleled support in optimizing their laboratory systems.

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