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5945 - GxP Instrument Systems Engineer / Senior Project Engineer

5945 - GxP Instrument Systems Engineer / Senior Project Engineer

Verista, Inc.Boston, MA, United States
1 day ago
Job type
  • Full-time
Job description

Overview

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The company empowers growth and innovation within the scientific community and helps researchers, organizations, and companies solve healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and reflect our investment in our people and capabilities.

Our growth is driven by world-class people who thrive in a team environment and share the mission to enable life sciences clients to improve lives. Our professionals are committed to making an impact every day.

Company Culture & Values

  • We empower and support our colleagues
  • We commit to client success at every turn
  • We have the courage to do the right thing
  • We encourage an inclusive environment where colleagues feel respected, engaged, and challenged
  • We continually acquire new skills and learn from experiences to enhance our collective expertise

Role

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 CDS, 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 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
  • On-site availability 3-4 days / week between Marlborough, MA and Norwood, MA locations

    • Compensation

    National (US) Range : $85,000 - $136,225 USD

    Equal Opportunity

    Verista is an equal opportunity employer.

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    Instrument Engineer • Boston, MA, United States

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