Validation Engineer

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

We are seeking a detail-oriented and motivated Entry-Level Validation Engineer to support qualification and validation activities within a regulated pharmaceutical or life sciences environment. The role will support equipment, utilities, processes, and computerized systems while ensuring compliance with cGMP, FDA, and company quality standards.

Key Responsibilities:

• Validation Execution: Assist with planning, preparing, and executing validation activities, including IQ, OQ, and PQ.
• Equipment Qualification: Support qualification of manufacturing equipment, laboratory systems, and critical utilities.
• Process Validation: Assist with process validation activities, protocols, reports, and data review.
• Documentation Management: Prepare and maintain validation protocols, summary reports, SOPs, and traceability documents.
• Commissioning Support: Assist with URS, DQ, FAT, SAT, commissioning, and qualification activities.
• Regulatory Compliance: Ensure validation activities comply with cGMP, FDA, GDP, and applicable regulatory requirements.
• Deviation & CAPA Support: Assist with deviation investigations, root-cause analysis, risk assessments, and CAPA activities.
• Lifecycle Management: Support periodic reviews, change controls, requalification, and ongoing validation activities.
• Cross-Functional Collaboration: Work with QA, QC, Engineering, Manufacturing, and Automation teams to meet validation requirements.
• Audit Readiness: Maintain accurate and complete validation documentation to support internal and external regulatory inspections.

Required Skills:

• Bachelor’s degree in Pharmaceutical Engineering, Chemical Engineering, Biotechnology, Life Sciences, or a related field.
• 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, and pharmaceutical manufacturing practices.
• Preferred understanding of Computerized System Validation (CSV) and 21 CFR Part 11.
• Strong technical writing, documentation, and communication skills.
• Excellent attention to detail and analytical problem-solving abilities.
• Fresh graduates and candidates with 0–2 years of relevant experience are encouraged to apply.