Validation Engineer

Job Description

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.

The Validation Engineer is responsible for authoring and executing key validation and qualification documentation to ensure equipment, systems, and processes comply with regulatory and company standards. This role also provides technical support across teams, including formulation, calibration, and maintenance operations, to maintain validated states and ensure data integrity throughout the product lifecycle.

Key Responsibilities

Author :

Equipment Operation SOPs and Sampling Plan SOPs

Validation Master Plans (VMPs)

Performance Qualification (PQ) Protocols

Requalification Procedures for Controlled Temperature Units (CTUs)

Support / Perform :

Corrective and Preventive Actions (CAPAs)

Field Use Evaluation (FUE) Reports

Annual Requalification of CTUs

System and Computer System Validation (CSV) Assessments

Review and approval of Calibration and Maintenance Work Orders

Formulation Team Support :

Author PQ Protocols for formulation-related equipment

Support Technical Transfer Change Controls

Coordinate and support PQ batch execution for relevant equipment

Qualifications

Bachelor’s degree in Engineering, Life Sciences, or related field

3+ years of experience in equipment validation or process qualification within a GMP-regulated environment

Strong understanding of FDA, EMA, and cGMP requirements

Experience with validation documentation, change controls, and deviation management

Excellent attention to detail, organization, and cross-functional communication skills

Benefits : 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.