Lead Validation Engineer - Pharma Processes & 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 plan

Paid time off

Education benefits

Job summary

Phlow Corp in Petersburg, VA seeks a Senior Validation Engineer to lead validation lifecycle activities across qualification, process, cleaning and commissioning. You will author protocols, support field activities, evaluate data, and drive continuous improvement in line with cGMP and FDA expectations.

The role requires hands-on experience with IQ/OQ/PQ, risk assessments, and documentation, plus strong cross-functional collaboration with Engineering, Manufacturing, QA, and Regulatory Affairs.

Qualifications

• 5-7 years of validation experience in pharmaceutical/biotech or regulated manufacturing environments.
• Experience developing, executing, and supporting IQ/OQ/PQ activities.
• Familiarity with cGMP, FDA regulations, and validation standards; strong technical writing skills.

Responsibilities

• Lead validation projects through full lifecycle—planning, execution, reporting, and closeout.
• Author/review commissioning and qualification docs (URS, FAT, SAT, IQ, OQ, PQ).
• Develop, execute, and report process validation and CPV/PPQ activities.
• Coordinate cleaning validation strategies and study execution (HBEL/PDE/MACO).
• Ensure compliance with cGMP, FDA regs, and internal procedures; support audits.

Skills

Project management

Technical writing

Cross-functional teamwork

Analytical problem-solving

Education

Bachelor's degree in Engineering/ Chemistry/ Pharmaceutical Sciences

Tools

Veeva

DeltaV

HPLC

Job description

Phlow Corp in Petersburg, VA seeks a Senior Validation Engineer to lead validation lifecycle activities across qualification, process, cleaning and commissioning. You will author protocols, support field activities, evaluate data, and drive continuous improvement in line with cGMP and FDA expectations.

The role requires hands-on experience with IQ/OQ/PQ, risk assessments, and documentation, plus strong cross-functional collaboration with Engineering, Manufacturing, QA, and Regulatory Affairs.