cGMP Lab Engineer (CSV/CSA Principles) jobs in United States
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ELIQUENT Life Sciences · 17 hours ago

cGMP Lab Engineer (CSV/CSA Principles)

positionCollege Station, TX
timeContract
remoteOnsite
seniorityMid Level
date4+ years exp

ELIQUENT Life Sciences is seeking an experienced Laboratory Engineer to join their Engineering - Central team. This role is responsible for supporting the design, operation, maintenance, and continuous improvement of pharmaceutical laboratory equipment and systems, ensuring compliance with cGMP and regulatory requirements.

ConsultingMedical DeviceProfessional Services
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H1B Sponsor Likelynote

Responsibilities

Provide engineering and technical support for QC, analytical, and development laboratories
Support installation, qualification, and lifecycle management of laboratory equipment and instruments
Coordinate and execute IQ/OQ/PQ activities for laboratory systems in collaboration with Validation and QA
Troubleshoot laboratory equipment issues and coordinate repairs, calibration, and vendor service
Author and review laboratory engineering documentation, including URS, specifications, SOPs, and change controls
Ensure laboratory equipment and systems comply with cGMP, data integrity (ALCOA+), and safety requirements
Support upgrades, relocations, and decommissioning of laboratory equipment
Partner with IT, Automation, and QA for CSV/CSA support of computerized lab systems
Support laboratory utilities such as gases, vacuum, power, temperature, and humidity control
Participate in deviation investigations, CAPAs, and root cause analysis related to laboratory equipment
Support internal audits and regulatory inspections

Qualification

CGMP regulationsLaboratory equipment qualificationCSV/CSA principlesAnalytical instrumentsEngineering drawings interpretationCleanroom environmentsTechnical writing

Required

Bachelor's degree in Engineering (Chemical, Mechanical, Electrical, Biomedical) or related technical discipline
At least 4 years of experience supporting laboratories in pharmaceutical, biotech, or regulated environments
Experience with laboratory equipment qualification and maintenance
Knowledge of cGMP regulations and laboratory compliance requirements
Ability to interpret engineering drawings, specifications, and technical manuals
Strong documentation and technical writing skills
Experience supporting QC laboratories and stability labs
Familiarity with analytical instruments (HPLC, GC, LC-MS, dissolution, TOC, endotoxin, etc.)
Knowledge of CSV/CSA principles for lab systems (LIMS, CDS, Empower, LabWare)
Experience with cleanroom and controlled laboratory environments

Preferred

Principal Consultants preferred

Company

ELIQUENT Life Sciences

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ELIQUENT Life Sciences is a regulatory consulting firm for the life sciences industry.
location
Washington, District of Columbia, USA
people-size501-1000 employees
web-link
https://eliquent.com

H1B Sponsorship

ELIQUENT Life Sciences has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (29)
2024 (3)

Funding

Current Stage
Late Stage

Leadership Team

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Stephen Purtell
Chief Financial Officer
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Rob Wojciechowski
Chief Operating Officer
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Recent News

Business Wire India
ELIQUENT Life Sciences Announces Strategic Acquisition of Azzur Consulting – Strengthening Full-Service Quality & Compliance Capabilities
2025-05-08
citybiz
ELIQUENT Life Sciences Acquires Azzur Consulting
2025-05-08
globallegalchronicle.com
ELIQUENT Life Sciences’ Acquisition of Truliant Consulting
2025-04-07
Company data provided by crunchbase