Junior Validation Engineer - GMP/FDA Compliance

Virtue America; United States; On-site; USD 55,000 - 80,000; Full time

Job summary

Virtue America is seeking an Entry-Level Validation Engineer to support qualification and validation activities in a regulated pharmaceutical or life sciences environment.

You will assist with IQ/OQ/PQ activities, equipment qualification, process validation, and documentation management while ensuring compliance with cGMP, FDA, and GDP standards. Fresh graduates are encouraged to apply.

Qualifications

• Strong technical writing, documentation, and communication skills.
• Excellent attention to detail and analytical problem-solving abilities.
• Basic understanding of the validation lifecycle and qualification concepts.
• Familiarity with IQ, OQ, PQ, URS, DQ, FAT, and SAT.
• Basic knowledge of cGMP, GDP, FDA regulations.

Responsibilities

• Assist with planning, preparing, and executing validation activities across IQ/OQ/PQ.
• Support qualification of manufacturing equipment, laboratory systems, and critical utilities.
• Assist with process validation activities, protocols, reports, and data review.
• Prepare and maintain validation protocols, summary reports, SOPs, and traceability documents.
• Assist with URS, DQ, FAT, SAT, commissioning and qualification activities.
• Ensure validation activities comply with cGMP, FDA, GDP standards.
• Assist with deviation investigations, root-cause analysis, risk assessments, and CAPA.
• Support lifecycle management including periodic reviews and change controls.
• Collaborate with QA, QC, Engineering, Manufacturing, and Automation teams.
• Maintain audit readiness with complete validation documentation.

Skills

Technical writing

Attention to detail

Analytical problem solving

Regulatory concepts familiarity

Education

Bachelor’s degree in Pharmaceutical Eng/ Chemical Eng/ Biotechnology/ Life Sciences

Tools

CSV knowledge

Job description

Virtue America is seeking an Entry-Level Validation Engineer to support qualification and validation activities in a regulated pharmaceutical or life sciences environment.

You will assist with IQ/OQ/PQ activities, equipment qualification, process validation, and documentation management while ensuring compliance with cGMP, FDA, and GDP standards. Fresh graduates are encouraged to apply.