ATL01-051925 Lab Quality Systems Engineer (MA)
ATL01-051925 Lab Quality Systems Engineer (MA)
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Salary Not Disclosed
1 Vacancy
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:
MondayFriday 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:
Bachelors 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.
Indepth 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 riskbased qualification methodologies for computerized systems.
Strong technical and interpersonal communication skills.
Employment Type
Full Time
