Senior Engineer – Lab Systems (Cell Therapy)

TSR Consulting; Harvard (MA); On-site; USD 48,154 - 68,583; Part time

Job summary

A consulting firm in Harvard is seeking a Senior Engineer – Lab Systems to enhance benchtop instrumentation applications within a GxP-regulated environment. The role involves leading quality administration, participating in validation activities, and supporting IT quality initiatives. Candidates should have a Bachelor's degree and at least 2 years of experience in regulated industries such as Biotech or Pharmaceuticals. The position offers up to $42.37 per hour based on experience.

Qualifications

• Bachelor’s degree or equivalent experience in relevant field.
• 2+ years of experience in Biotech, Pharmaceutical, or Medical Devices.
• Experience supporting laboratory instruments within GxP environments.

Responsibilities

• Lead administration of quality and laboratory applications.
• Participate in Computer System Validation (CSV) activities.
• Provide IT quality support to the Digital Plant team.

Skills

Communication

Leadership

Project coordination

Data integrity

SDLC

cGMP

Education

Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field

Tools

Waters NuGenesis

FCS Express

Veeva Document Management System

Infinity QMS

ServiceNow

Job description

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)

Position Summary

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.

Key Responsibilities

• 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 ServiceNow.
• 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.

Required Qualifications

• 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.

Preferred Skills

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