Lead Validation Engineer - Pharma Processes & Compliance

Phlow Corp; Petersburg (VA); Sur place; USD 120 000 - 150 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Life insurance

Disability insurance

Retirement plan

Paid time off

Education benefits

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Project management

Technical writing

Cross-functional teamwork

Analytical problem-solving

Formation

Bachelor's degree in Engineering/ Chemistry/ Pharmaceutical Sciences

Outils

Veeva

DeltaV

HPLC

Description du poste

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.