Process Validation Engineer

Clark & Enersen; Greenville (NC); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Life insurance

401(k) with employer match

Paid time off

Job summary

ELIQENT Life Sciences is seeking a Process Validation Engineer to support pharmaceutical manufacturing projects, including new fill line implementation and revalidation activities. Responsibilities include developing validation strategies, coordinating aseptic media fills, and assisting with tech transfers.

The role emphasizes cGMP compliance, risk assessments, and CQV/documentation support, with a focus on aseptic processing environments and PFS lines. Flexible work arrangements are offered.

Qualifications

• Smoke studies experience in pharmaceutical manufacturing.
• Knowledge of cGMP/compliance is implied by regulatory contexts.

Responsibilities

• Develop and execute process validation strategies for new fill line projects.
• Support PPQ studies and validation activities.
• Coordinate and evaluate aseptic media fill runs.
• Perform revalidation activities for pre-filled syringe fill lines.
• Support tech transfer projects across new and existing manufacturing lines.
• Conduct risk assessments and ensure cGMP compliance.
• Support CQV, qualification, and validation documentation activities.
• Conduct and support smoke studies for aseptic processing environments.
• Assist in qualification of automated visual inspection systems.

Skills

Smoke Studies

Pharmaceutical Manufacturing

Job description

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Process Validation Engineer

30+ days ago Requisition ID: 1308

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 Process Validation Engineer to support pharmaceutical manufacturing projects, including a new fill line implementation and revalidation activities.

Key Responsibilities:

• Develop and execute process validation strategies for new fill line projects
• Support Process Performance Qualification (PPQ) studies and validation activities
• Coordinate and evaluate aseptic media fill runs
• Perform revalidation activities for pre-filled syringe (PFS) fill lines
• Support tech transfer projects across new and existing manufacturing lines
• Conduct risk assessments and ensure cGMP compliance
• Support CQV, qualification, and validation documentation activities
• Conduct and support smoke studies for aseptic processing environments
• Support qualification of automated visual inspection systems

Required Skills:

• Smoke Studies
• Pharmaceutical Manufacturing Experience

Preferred Skills:

• Pre-Filled Syringe (PFS) Fill Line Experience

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.