Pharma Process Validation Engineer - Flexible Work & Growth

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

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.