GxP Instrument Systems Engineer- Norwood, MA

ZipRecruiter; Washington; Remote; USD 100,000 - 125,000; Full time

Job summary

A leading automation firm is seeking a GxP Instrument Systems Engineer to manage the design and implementation of digital laboratory systems. This role requires 5-7 years of experience in life sciences enterprise systems and direct experience with automation solutions. The position is remote, requiring on-site presence 3-4 days a week between Marlborough and Norwood, MA. Ideal candidates will have strong interpersonal skills and a firm understanding of GxP compliance.

Qualifications

• 5 to 7+ years experience in designing and managing life sciences enterprise systems.
• Direct experience with automation solutions like Hamilton Venus.
• Ability to work independently and effectively communicate across functions.

Responsibilities

• Manage change control for regulatory documentation.
• Identify opportunities to optimize current processes.
• Participate in internal and external audits as required.

Skills

Designing enterprise systems

Automation solutions

Laboratory digital workflow optimization

GxP compliance regulations

Interpersonal skills

Education

Bachelor's degree in science, engineering, or computer science

Tools

Hamilton Venus

Waters Andrew+

Oxford Nanopore

Job description

Overview

The qualified GxP Instrument Systems Engineer / Senior Project Engineer will be responsible for the design, deployment and management of automation and digital enterprise instrumentation systems that support Quality Control laboratories and system integration with connected Digital platforms.

Responsibilities

• Collaborate with Business Analysts and Software/Automation Engineers in the complete product lifecycle management of Digital Quality Automation Systems (Hamilton Venus, Waters Andrew+ with OneLab, etc.) and Enterprise Instrumentation Systems (Chromeleon Chromatography Data System, Scientific Data Management System (LogiLab), CFR Gateway (LogiLab), SoftMax Pro, MODA, etc.) including optimizations, support, maintenance updates and version upgrades
• Translate system/equipment/data integration requirements from various teams into deployable Digital Laboratory System solutions
• Manage change control for regulatory Digital documentation (SOPs, work instructions, etc.) required to demonstrate appropriate compliance
• Partner with stakeholders to validate and integrate key systems into the connected instrument pipeline, future robotics/automation capabilities and AI initiatives
• Identify opportunities to optimize current processes and implement upgraded solutions
• Ensure GMP compliance in the design, delivery and maintenance of all systems
• Maintain inspection readiness throughout the duration of the project
• Participate in internal and external audits as required

Requirements

• Bachelors degree or equivalent in science, engineering or computer science discipline
• 5 to 7+ years experience designing, implementing, and managing life sciences enterprise systems (CDS, SDMS, LIMS, ELN, LES) in a biopharmaceutical GMP environment
• Direct experience with automation solutions such as Hamilton Venus
• Experience working with advanced automated laboratory analytical systems such as Waters Andrew+, Oxford Nanopore, and Hamilton Venus liquid handlers
• Experience with GAMP and GxP compliance regulation
• Experience with data integrity regulations, instrument integration and laboratory digital workflow optimization
• Experience with Digital systems hosted in the cloud and an understanding of connectivity between on-prem systems and SAAS/Cloud
• Strong understanding of core laboratory systems, related processes, and quality management workflows
• Ability to work independently and in a team setting, with the ability to effectively communicate cross-functionally
• Ability to support multiple concurrent projects in a fast-paced environment
• Strong interpersonal and relationship-building skills

Location

On-site 3-4 days/week between Marlborough, MA and Norwood, MA

This is a remote position.