Senior GxP Instrument Systems Engineer

Pharmatek Consulting Inc.; Marlborough (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading biotech consulting firm in Marlborough is seeking an experienced Instruments Engineer to design and manage automation systems for Quality Control laboratories. Candidates must have a Bachelor’s degree and extensive experience with life sciences enterprise systems and GxP compliance. Responsibilities include collaborating with stakeholders, managing project documentation, and ensuring GMP compliance. This on-site position requires strong interpersonal skills and the ability to manage multiple projects in a fast-paced environment.

Qualifications

• 5 to 7+ years’ experience in designing and managing life sciences enterprise systems.
• Experience with advanced automated laboratory analytical systems.
• Ability to work independently and in a team setting.

Responsibilities

• Collaborate with analysts and engineers in managing Digital Quality Automation Systems.
• Manage change control for regulatory Digital documentation.
• Validate and integrate key systems into the connected instrument pipeline.

Skills

Experience with automation solutions such as Hamilton Venus

Experience with GAMP and GxP compliance regulation

Strong interpersonal and relationship-building skills

Ability to support multiple concurrent projects

Education

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

Tools

Chromeleon Chromatography Data System

Waters Andrew+

Hamilton Venus

Job description

Marlborough, United States | Posted on 09/26/2025

• Industry Pharma/Biotech/Clinical Research
• Job Type Full time
• Work Experience 5+ years
• City Marlborough
• State/Province Massachusetts
• Country United States

Job Description

For a Biotech Company We are looking for an Instruments Engineer:

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.

Location

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

Job 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

Bachelor’s 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 bio pharmaceutical 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