CGMP Lab Engineer; CSV​/CSA Principles

This is a 5 day a week onsite consulting assignment. No phone calls please. We will call you after reviewing your resume if we're interested. Principal Consultants preferred.

No 3rd Parties!!!

We at ELIQUENT are looking for an experienced Laboratory Engineer to immediately join our ELIQUENT Engineering - Central team. The Laboratory Engineer is responsible for supporting the design, operation, maintenance, and continuous improvement of pharmaceutical laboratory equipment and systems. This role ensures laboratory instruments, utilities, and infrastructure operate reliably and in compliance with cGMP, data integrity, and regulatory requirements, supporting QC, analytical, and R&D laboratory operations.

ESSENTIAL DUTIES AND 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

QUALIFICATIONS AND REQUIREMENTS:

• 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, Lab Ware)
• Experience with cleanroom and controlled laboratory environments