Validation Engineer

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 is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients’ needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices. For more information, please visit our website at eliquent.com.

We are seeking a highly skilled Commissioning, Qualification, and Validation (CQV) Engineer to join our consulting team. The CQV Engineer will play a crucial role in ensuring the successful commissioning, qualification, and validation of facilities, equipment, and processes in the pharmaceutical, biotechnology, and medical device industries. The ideal candidate will possess strong technical expertise, project management skills, and a thorough understanding of regulatory requirements.

Key Responsibilities:

• Develop and execute commissioning and qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of Facilities, Utilities and Equipment (tanks/vessels, centrifuges, filter presses, etc.)
• Coordinate and oversee the installation, testing, and validation of equipment and systems
• Ensure compliance with regulatory guidelines (FDA, EMA, etc.) and industry standards (GMP, GxP)
• Prepare and review validation documentation, including Validation Master Plans (VMP), User Requirement Specifications (URS), and risk assessments
• Perform validation activities for processes, systems, and equipment, including writing and executing test plans and reports
• Identify and resolve deviations and non-conformities, ensuring timely corrective actions
• Communicate effectively with clients, project teams, and stakeholders to ensure project objectives are met
• Provide technical guidance and mentorship to junior team members
• Contribute to the development and implementation of best practices and standard operating procedures (SOPs) in CQV activities
• Stay current with industry trends, technological advancements, and regulatory changes

Requirements

• Lead and execute validation activities for lyophilizers, including cycle development, qualification (IQ/OQ/PQ), and performance monitoring.
• Support validation and qualification of fill‑finish equipment, such as filling lines, isolators/RABS, cappers, and associated utilities.
• Plan, coordinate, and execute media fill (aseptic process simulation) activities in compliance with regulatory expectations.
• Develop and author validation protocols, reports, risk assessments, and supporting documentation.
• Partner with Manufacturing, Quality, Engineering, and Technical Operations to ensure validated state of equipment and processes.
• Troubleshoot validation deviations, perform root‑cause analysis, and implement corrective/preventive actions (CAPA).
• Maintain compliance with FDA, EMA, and global GMP requirements related to aseptic processing and equipment validation.
• Support change controls, equipment upgrades, and continuous improvement initiatives.
• Ensure validation activities are executed safely, on schedule, and aligned with project timelines.

What We Offer:

• Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience.
• Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment.
• Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance.

Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.