GxP Systems Engineer

Norwood & Marlborough, MA (Onsite)
Contract
Client: Moderna

Job Overview

We are seeking an experienced GxP Systems Engineer to support the design, deployment, integration, and lifecycle management of Digital Quality and laboratory automation systems within a GMP-regulated biopharmaceutical environment. The ideal candidate will have strong experience supporting analytical instrumentation, laboratory automation platforms, digital quality systems, and regulated validation processes.

This role will partner closely with Quality Control laboratories, Digital teams, Automation Engineers, and business stakeholders to ensure compliant, scalable, and efficient laboratory system operations across connected enterprise platforms.

Key Responsibilities

• Design, deploy, configure, and support Digital Quality Automation Systems and analytical laboratory instrumentation in GMP environments
• Support lifecycle management activities including implementation, upgrades, maintenance, troubleshooting, optimization, and validation
• Work with laboratory automation platforms such as Hamilton Venus and connected digital integration solutions such as Scitara DLX
• Integrate laboratory instruments and automation systems with enterprise Digital platforms, cloud applications, and on-prem infrastructure
• Translate business and technical requirements into scalable laboratory digital solutions
• Support Computer System Validation (CSV) activities including IQ/OQ/PQ documentation, testing, and compliance deliverables
• Maintain and manage GMP documentation including SOPs, work instructions, change controls, validation protocols, and knowledge base articles
• Ensure systems comply with GxP, GAMP5, data integrity, and 21 CFR Part 11 requirements
• Collaborate with cross-functional teams supporting QC laboratories, automation initiatives, robotics platforms, and AI-driven digital programs
• Participate in internal and external audits and maintain inspection readiness for supported systems
• Identify opportunities for process optimization, automation, and operational efficiency improvements
• Support hybrid infrastructure connectivity between on-prem systems and SaaS/Cloud-hosted platforms
• Provide hands-on troubleshooting and technical support for laboratory digital systems and instrumentation

Required Qualifications

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field
• 5+ years of experience supporting laboratory systems, analytical instrumentation, or automation platforms within a GMP-regulated biopharmaceutical environment
• Hands-on experience with laboratory automation systems such as Hamilton Venus preferred
• Strong understanding of GxP, GMP, GAMP5, Computer System Validation (CSV), and data integrity regulations
• Experience supporting laboratory instrumentation integration and digital laboratory workflows
• Knowledge of cloud-hosted Digital systems and integration with on-prem infrastructure
• Experience managing validation documentation, SOPs, change controls, and regulated system lifecycle activities
• Familiarity with Linux/Ubuntu commands and system administration concepts is a plus
• Strong troubleshooting, analytical, and problem-solving skills
• Ability to work independently in a fast-paced, highly collaborative environment

Preferred Qualifications

• Experience with Scitara DLX or similar laboratory integration platforms
• Experience supporting QC laboratory environments in pharmaceutical or biotechnology organizations
• Knowledge of LIMS, ELN, laboratory informatics, and instrument connectivity solutions
• Familiarity with robotics, automation workflows, and digital transformation initiatives in life sciences
• Strong communication and stakeholder management skills
• Experience participating in FDA or regulatory audits

Technical Skills

• GxP / GMP Compliance
• GAMP5
• Computer System Validation (CSV)
• Hamilton Venus
• Laboratory Automation
• Instrument Integration
• Analytical Instruments
• Scitara DLX
• Linux / Ubuntu
• Cloud & SaaS Connectivity
• Data Integrity
• Change Control
• SOP Documentation
• QC Laboratory Systems
• 21 CFR Part 11

Thanks & Regards,

Akshay Kumar

Talent Acquisition- Recruitment

Global Applications Solution LLC(USA)

Office USA: +1 | Whatsapp: +91 7562 863220