GxP Systems Engineer

United Pharma Technologies Inc; Massachusetts; On-site; USD 90,000 - 120,000; Full time

Job summary

United Pharma Technologies Inc is looking for an experienced GxP Systems Engineer to design, deploy, and manage advanced digital quality automation systems in a GMP-regulated environment. The ideal candidate will have 5–7+ years of experience with laboratory instrumentation and automation platforms, along with strong GxP compliance knowledge. Responsibilities include supporting the full product lifecycle, optimizing laboratory workflows, and ensuring compliance and inspection readiness while collaborating across multiple projects and teams.

Qualifications

• 5–7+ years of experience in GMP-regulated biopharmaceutical environment.
• Hands-on experience with laboratory automation platforms.
• Strong understanding of GxP, GAMP, and GMP compliance.

Responsibilities

• Collaborate with business analysts and software engineers on product lifecycle management.
• Support implementation and maintenance of digital quality automation systems.
• Drive continuous improvement initiatives in laboratory digital workflows.

Skills

Laboratory automation systems

GxP compliance

Analytical instrumentation

Digital workflow optimization

Collaboration across teams

Education

Bachelor’s degree in Engineering, Computer Science, Life Sciences

Tools

Hamilton Venus

SpectraMax M5

Linux Ubuntu

Job description

We are seeking an experienced GxP Systems Engineer to support the design, deployment, integration, and lifecycle management of advanced digital quality and laboratory automation systems within a GMP-regulated biopharmaceutical environment. The ideal candidate will have strong expertise in laboratory instrumentation, automation platforms, digital system integration, and GxP compliance, with the ability to collaborate across cross-functional teams in a fast-paced environment.

Key Responsibilities

• Collaborate with internal and external business analysts, software engineers, and automation engineers to support the full product lifecycle management of Digital Quality Automation Systems and standalone analytical instrumentation.
• Support implementation, optimization, maintenance, troubleshooting, updates, and version upgrades for systems such as Hamilton Venus, Scitara DLX, SpectraMax M5, Hamilton Liquid Pipetting systems, and related laboratory technologies.
• Translate business, system, and data integration requirements into scalable digital laboratory solutions within GMP environments.
• Manage and support change control activities and regulatory documentation including SOPs, work instructions, knowledge base articles, and lifecycle documentation.
• Partner with digital stakeholders to validate and integrate systems into connected laboratory instrument pipelines, robotics platforms, automation initiatives, and AI-enabled solutions.
• Drive innovation and continuous improvement initiatives by identifying opportunities to optimize laboratory digital workflows and operational processes.
• Ensure GMP compliance is incorporated into the design, deployment, validation, and maintenance of all systems.
• Maintain inspection readiness through adherence to quality procedures, training requirements, and compliance standards.
• Participate in internal and external audits as the digital quality systems subject matter expert.
• Support multiple concurrent projects while collaborating within a cross-functional matrix organization.
• Travel between regional sites as required.
• Perform additional responsibilities as assigned.

Required Qualifications

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related technical field.
• 5–7+ years of experience designing, implementing, and managing analytical instrumentation and digital laboratory systems within a GMP-regulated biopharmaceutical environment.
• Hands-on experience with laboratory automation platforms such as Hamilton Venus or similar systems.
• Strong understanding of GxP, GAMP, and GMP compliance requirements.
• Experience with laboratory systems, instrument integration, data integrity regulations, and digital workflow optimization.
• Experience supporting cloud-hosted digital systems and understanding connectivity between on-premise systems and SaaS/Cloud environments.
• Experience with Linux Ubuntu SUDO commands is preferred.

Preferred Qualifications

• Strong analytical, troubleshooting, and problem-solving skills with a continuous improvement mindset.
• Ability to work independently and make effective technical decisions in a fast-paced environment.
• Strong knowledge of laboratory systems, quality management workflows, and digital quality processes.
• Excellent communication and interpersonal skills with the ability to build strong cross-functional relationships.
• Ability to manage multiple priorities and projects simultaneously.
• Experience working within highly collaborative, matrixed organizations.
• Passion for innovation, automation, and digital transformation within the life sciences industry.