Senior Engineer – Lab Systems; Cell Therapy

Job Title: Senior Engineer – Lab Systems (Cell Therapy)

Schedule: Monday–Friday | 8:00 AM – 5:00 PM

Duration: 06 Months Contract

Pay Rate: $42.37/hour (W2)

We are seeking a Senior Engineer – Lab Systems to support and enhance benchtop instrumentation applications, PC hardware, and IT administrative tools within a GxP-regulated environment
. The role will support laboratory and manufacturing operations involving instruments such as cellometers, plate readers, and flow cytometers while ensuring compliance with CSV, cGMP, and data integrity standards
.

• Lead and support administration of quality and laboratory applications
  , including lifecycle management and technical support.
• Participate in Computer System Validation (CSV) activities including risk assessments, validation documentation, and qualification testing.
• Provide IT quality support to the Digital Plant team through review and approval of investigations, change controls, and deviations
  .
• Manage quality events within the Infinity Quality Management System
  , including investigations, root cause analysis, and CAPA documentation.
• Review and approve digital change requests through Service Now
  .
• Ensure SOPs and procedural methodologies are maintained and updated to preserve the validated state of systems.
• Participate in regulatory audits and assist in responses to audit observations.
• Support system maintenance and Digital Plant initiatives within laboratory and manufacturing environments.
• Mentor team members and provide guidance on compliance and validation processes.
• Support on-call deviation management on a rotational basis.

• Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field (or equivalent experience).
• 2+ years of experience in regulated industries such as Biotech, Pharmaceutical, or Medical Devices
  .
• Experience supporting benchtop laboratory instruments and applications within GxP environments
  .
• Strong knowledge of Data Integrity, SDLC, cGMP, and Good Documentation Practices
  .
• Familiarity with FDA/EU regulatory guidelines and working within regulated environments.
• Understanding of networks, databases, servers, and PCs
  .
• Excellent communication, leadership, and project coordination skills.

• Experience with Waters NuGenesis, FCS Express, Veeva Document Management System, Infinity QMS, and Service Now
  .
• Exposure to Lean or Operational Excellence (OpEx) methodologies.
• Ability to lead small to medium system enhancement projects
  .