Overview
Hybrid
Depends on Experience
Accepts corp to corp applications
Contract - W2
Contract - Independent
Contract - 12 Month(s)
Skills
Artificial Intelligence
Auditing
Change Control
Cloud Computing
Collaboration
Data Integration
Data Integrity
Documentation
ELN
GAMP
GMP
GxP
Inspection
Instrumentation
LES
LIMS
Life Sciences
Lifecycle Management
Management
Process Optimization
Systems Design
Quality Control
Regulatory Compliance
Relationship Building
Robotics
SaaS
Workflow
Workflow Optimization
GxP Instrument Systems Engineer
Instrument Systems Engineer
GxP Engineer
GxP Instrument Engineer
Systems Engineer
Instrument
Systems
Engineer
Instrument Engineer
Job Details
Position: GxP Instrument Systems Engineer
Location: Norwood, MA (Hybrid Model)
Job Type: Contract long-term
Job Description:
The GxP Instrument Systems Engineer / Senior Project Engineer will lead the design, deployment, and management of automation and digital enterprise instrumentation systems supporting Quality Control laboratories and integration with connected digital platforms.
Required Qualifications:
- Bachelor s degree in science, engineering, or computer science (or equivalent).
- 5 7+ years of experience with life sciences enterprise systems (CDS, SDMS, LIMS, ELN, LES) in a GMP biopharma environment.
- Hands-on experience with automation tools like Hamilton Venus.
- Familiarity with advanced automated lab systems (Waters Andrew+, Oxford Nanopore, Hamilton Venus).
- Knowledge of GAMP and GxP compliance regulations.
- Understanding of data integrity, instrument integration, and digital workflow optimization.
- Experience with cloud-hosted digital systems and connectivity between on-prem and SaaS/cloud platforms.
- Strong grasp of laboratory systems, processes, and quality workflows.
- Ability to work independently and collaboratively across teams.
- Capable of managing multiple projects in a fast-paced environment.
- Excellent interpersonal and relationship-building skills.
Roles & Responsibilities:
- Collaborate with Business Analysts and Software/Automation Engineers on lifecycle management of Digital Quality Automation Systems (e.g., Hamilton Venus, Waters Andrew+ with OneLab) and Enterprise Instrumentation Systems (e.g., Chromeleon CDS, LogiLab SDMS, CFR Gateway, SoftMax Pro, MODA).
- Translate system/equipment/data integration requirements into deployable Digital Laboratory System solutions.
- Manage change control for regulatory digital documentation (SOPs, work instructions) to ensure compliance.
- Partner with stakeholders to validate and integrate systems into instrument pipelines, robotics/automation, and AI initiatives.
- Identify process optimization opportunities and implement upgraded solutions.
- Ensure GMP compliance in system design, delivery, and maintenance.
- Maintain inspection readiness throughout the project duration.
- Participate in internal and external audits as needed.
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