GxP Instrument Systems Engineer (Biotech)

TL;DR

GxP Instrument Systems Engineer (Biotech): Designing, deploying, and managing automation and digital enterprise instrumentation systems for Quality Control laboratories with an accent on GxP compliance and system integration. Focus on optimizing laboratory digital workflows, ensuring data integrity, and validating connected instrument pipelines within a biopharmaceutical GMP environment.

Location: Must be based in the US, with hybrid attendance required 3-4 days/week in Marlborough, MA and Norwood, MA.

Company

hirify.global is an IT consulting and permanent staffing firm providing specialized IT solutions and resources to leading corporations across various industries including telecommunications, ERP, and medical sectors.

What you will do

• Collaborate with analysts and engineers to manage the lifecycle of Digital Quality Automation and Enterprise Instrumentation Systems.
• Translate complex data integration requirements into deployable laboratory system solutions.
• Manage change control for regulatory digital documentation to ensure compliance.
• Partner with stakeholders to validate and integrate systems into connected instrument pipelines and automation initiatives.
• Ensure GMP compliance throughout the design, delivery, and maintenance of all laboratory systems.
• Maintain inspection readiness and participate in internal and external audits.

Requirements

• Bachelor’s degree in science, engineering, or computer science.
• 5-7+ years of experience managing life sciences enterprise systems (CDS, SDMS, LIMS, ELN, LES) in a GMP environment.
• Direct experience with automation solutions like Hamilton Venus and analytical systems such as Waters Andrew+.
• Strong knowledge of GAMP, GxP compliance, and data integrity regulations.
• Understanding of cloud-hosted digital systems and connectivity between on-prem and SaaS environments.
• Ability to work cross-functionally and support multiple concurrent projects.

Culture & Benefits

• Opportunity to work with a growing IT consulting firm on diverse, high-impact projects.
• Exposure to cutting-edge laboratory automation and AI initiatives in the biopharmaceutical sector.
• Collaborative environment with a focus on strategic IT service delivery.