Lead Pharma Validation Engineer – Process & Compliance

Phlow Corp; Petersburg (VA); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Medical insurance

Life insurance

Disability insurance

Retirement plans

Paid time off

Company holidays

Education benefits

Job summary

Phlow Corp is seeking a Senior Validation Engineer to support commissioning, qualification, and process validation activities at the Petersburg Campus. The role requires a hands-on professional who can develop strategies, author protocols, support field activities, resolve deviations, evaluate data, and complete final reports.

The position involves leading validation projects, writing and reviewing IQ/OQ/PQ docs, performing CPV/PPQ tasks, and ensuring adherence to FDA/cGMP standards.

Qualifications

• Bachelor’s degree in Engineering, Chemistry, Pharmaceutical Sciences, Life Sciences, or a related technical field.
• 5–7 years of validation experience in pharmaceutical, biotechnology, API, or other regulated manufacturing environments.
• Experience developing, executing, and/or supporting IQ, OQ, and PQ activities.
• Familiarity with process validation and cleaning validation principles and practices.
• Strong technical writing, documentation, organizational, and communication skills.
• Proven ability to work effectively in cross-functional teams in both manufacturing and office settings.
• Knowledge of cGMP, FDA regulations, and industry validation standards.

Responsibilities

• Lead validation projects through the full validation lifecycle, including planning, execution, reporting, and closeout.
• Author, review, and execute commissioning and qualification documentation (URS, FAT, IQ/OQ/PQ).
• Develop, execute, and report on PPQ and CPV protocols.
• Support regulatory inspections, customer audits, and internal audits with inspection-ready documentation.

Skills

Validation expertise

Technical writing

Cross-functional collaboration

FDA compliance

Education

Bachelor's degree (Engineering / related)

Tools

Veeva

DeltaV

HPLC

Job description

Phlow Corp is seeking a Senior Validation Engineer to support commissioning, qualification, and process validation activities at the Petersburg Campus. The role requires a hands-on professional who can develop strategies, author protocols, support field activities, resolve deviations, evaluate data, and complete final reports.

The position involves leading validation projects, writing and reviewing IQ/OQ/PQ docs, performing CPV/PPQ tasks, and ensuring adherence to FDA/cGMP standards.