CQV Validation Engineer — Pharma & Biotech

ELIQUENT Life Sciences; Greenville (NC); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Life insurance

401(k) with match

Paid time off

Job summary

ELIQUENT Life Sciences seeks a skilled CQV Engineer to lead commissioning, qualification, and validation of facilities and equipment for pharma/biotech manufacturing. You will develop IQ/OQ/PQ protocols, supervise installation and testing, and ensure adherence to FDA/EMA and GMP standards.

You will collaborate with Manufacturing, Quality, and Engineering to keep validated states current, write robust validation documentation, and mentor junior staff while driving continuous improvement in CQV

Qualifications

• Lead and execute validation activities for lyophilizers (IQ/OQ/PQ).
• Plan media fill (aseptic process simulation) activities.
• Develop and author validation protocols, reports, and risk assessments.
• Partner with Manufacturing, Quality, Engineering to ensure validated state.

Responsibilities

• Develop and execute IQ/OQ/PQ protocols for Facilities, Utilities and Equipment (tanks/vessels, centrifuges, filter presses).
• Coordinate installation, testing, and validation of equipment and systems.
• Ensure compliance with FDA/EMA and GMP/GxP standards.
• Prepare and review Validation Master Plans, URS, and risk assessments.
• Perform validation activities for processes, systems, and equipment; write tests and reports.
• Identify deviations and implement CAPA with root-cause analysis.
• Communicate with clients, project teams, and stakeholders to meet objectives.
• Provide mentorship to junior team members.
• Contribute to SOPs and best practices in CQV activities.
• Stay current with industry trends and regulatory changes.

Skills

IQ/OQ/PQ

Regulatory compliance

GMP/GxP

Validation documentation

Root-cause analysis

CAPA

Mentorship

Client communication

Job description

ELIQUENT Life Sciences seeks a skilled CQV Engineer to lead commissioning, qualification, and validation of facilities and equipment for pharma/biotech manufacturing. You will develop IQ/OQ/PQ protocols, supervise installation and testing, and ensure adherence to FDA/EMA and GMP standards.

You will collaborate with Manufacturing, Quality, and Engineering to keep validated states current, write robust validation documentation, and mentor junior staff while driving continuous improvement in CQV