ATL01-051925 Lab Quality Systems Engineer (MA)

ZipRecruiter; Harvard (MA); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading services supplier in the life sciences sector seeks a Laboratory Quality Systems Engineer to support project execution and maintenance of laboratory quality systems. The position involves extensive interaction with regulatory compliance as well as hands-on technical and administrative responsibilities in a dynamic manufacturing environment. Candidates need a solid background in regulated industries and robust problem-solving skills to improve compliance and efficiency.

Qualifications

• 5+ years of experience in a regulated industry supporting lab systems.
• In-depth knowledge of GxP, cGMP, SOPs, Data Integrity.
• Application administration and computer/server administration experience required.

Responsibilities

• Perform analytical instrument computer system qualification.
• Provide technical support for laboratory instruments.
• Maintain and manage asset data and ensure compliance with industry standards.

Skills

GxP

cGMP

Data Integrity

Documentation Practices

Technical Communication

Interpersonal Communication

Education

Bachelor’s degree in life sciences, engineering, computer science

Tools

ServiceNow

ALM

ValGenesis

Job description

Job Description

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Device industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to working under the highest ethical standards for the following position:

• Laboratory Quality Systems Engineer

Location:
Devens, MA (100% Onsite)

Schedule:
Monday–Friday, regular business hours.
Note: Candidate must be able to gown into a manufacturing environment on a weekly basis.

Description of Services:
Validation & Engineering Group is seeking to provide a qualified resource to support project execution and ongoing maintenance of laboratory quality systems and benchtop instrumentation at a regulated manufacturing site. The selected engineer will be responsible for the following services:

• Perform analytical instrument computer system qualification following internal procedures and under client direction.
• Administer and support benchtop instrumentation applications, PC hardware, and IT administrative tools in a GxP setting.
• Provide technical support for instruments such as ViCell, SoloVPE, Cary60, and Spectramax plate readers across laboratory and manufacturing areas.
• Lead or support activities within the local quality management system.
• Collaborate with global stakeholders to align solutions and implement plans for benchtop systems, including installations, configurations, qualifications, and training.
• Maintain and manage asset data, incidents, problems, and changes using systems such as ServiceNow.
• Generate and update documentation to ensure reliability, accessibility, and security of supported systems.
• Ensure compliance with internal directives and industry standards.
• Execute projects and technical assignments, serving as point of contact for stakeholders.
• Provide local administrative support for quality systems, including periodic reviews, user access reviews, and account administration.
• Act as a subject matter expert in digital plant systems, advising on configurations, data integrity, and cybersecurity.
• Identify and implement technology and process improvements to enhance compliance and efficiency.
• Create project and compliance deliverables aligned with agreed timelines and requirements.

Required Skills and Qualifications:

• Bachelor’s degree in life sciences, engineering, computer science, or equivalent experience.
• 5+ years of experience in a regulated industry (biotech, pharma, medical devices) supporting benchtop instrumentation and lab systems.
• In-depth knowledge of GxP, cGMP, SOPs, Data Integrity, SDLC, and Good Documentation Practices.
• Application administration experience, including configuration, upgrades, and backend support.
• Computer/server administration experience (hardware repair, folder permissions, Windows 7/10/11).
• Familiarity with electronic qualification systems (e.g., ALM, ValGenesis).
• Understanding of risk-based qualification methodologies for computerized systems.
• Strong technical and interpersonal communication skills.