Validation Engineer

Virtue America; United States; On-site; USD 55,000 - 75,000; Full time

Job summary

Virtue America is seeking an entry-level Validation Engineer to support equipment, process, utility, and computerized system validation within a regulated pharmaceutical or life sciences environment. You will assist with qualification, validation documentation, testing and ensuring compliance with cGMP and FDA requirements.

Key responsibilities include planning and executing validation activities (IQ/OQ/PQ), equipment qualification, process validation, documentation management, and regulatory

Qualifications

• Bachelor’s degree in pharmaceutical/chemical/mechanical/electrical engineering, biotechnology, life sciences or related field.
• Basic understanding of the validation lifecycle and qualification principles.
• Familiarity with IQ, OQ, PQ, URS, DQ, FAT, SAT.
• Basic knowledge of cGMP, GDP, FDA regulations.
• Preferred familiarity with CSV and 21 CFR Part 11.
• Strong technical writing, documentation, analytical and problem-solving skills.
• Excellent attention to detail and communication skills.
• Fresh graduates and 0–2 years of relevant experience encouraged to apply.

Responsibilities

• Assist with planning, preparing, and executing validation activities, including IQ, OQ, and PQ.
• Support qualification of equipment, laboratory equipment, and critical utilities.
• Assist with process validation protocols, execution, data review, and summaries.
• Prepare and maintain validation protocols, reports, SOPs, traceability matrices, and supporting documents.
• Assist with URS, DQ, FAT, SAT, commissioning and qualification activities.
• Ensure validation activities comply with cGMP, FDA, GDP and regulatory standards.
• Assist with deviation investigations, root-cause analysis, risk assessments, and CAPA.
• Support validation-related change controls, periodic reviews, requalification and lifecycle activities.
• Collect, review, and analyze validation data to verify performance.
• Collaborate with QA, QC, Manufacturing, Engineering, Automation and other teams to support validation schedules.
• Maintain audit readiness with complete validation records.

Skills

Attention to detail

Technical writing

Analytical

Communication

Fresh graduates welcome

Education

Bachelor’s degree in Pharmaceutical Engineering or related field

Tools

CSV (Computerized System Validation)

Job description

We are seeking a detail-oriented and motivated Entry-Level Validation Engineer to support equipment, process, utility, and computerized system validation activities within a regulated pharmaceutical or life sciences environment. The role will assist with qualification, validation documentation, testing, and compliance activities while ensuring adherence to cGMP and FDA requirements.

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 equipment, and critical utilities.
• Process Validation: Assist with process validation protocols, execution, data review, and summary reports.
• Documentation Management: Prepare and maintain validation protocols, reports, SOPs, traceability matrices, and supporting 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 standards.
• Deviation & CAPA Support: Assist with deviation investigations, root-cause analysis, risk assessments, and CAPA activities.
• Change Control: Support validation-related change controls, periodic reviews, requalification, and lifecycle activities.
• Data Analysis: Collect, review, and analyze validation data to verify process and equipment performance.
• Cross-Functional Collaboration: Work with QA, QC, Manufacturing, Engineering, Automation, and other project teams to support validation schedules.
• Audit Readiness: Maintain accurate and complete validation records to support internal and external regulatory inspections.

Required Skills:

• Bachelor’s degree in Pharmaceutical Engineering, Chemical Engineering, Mechanical Engineering, Electrical Engineering, Biotechnology, Life Sciences, or a related field.
• Basic understanding of the validation lifecycle and qualification principles.
• Familiarity with IQ, OQ, PQ, URS, DQ, FAT, and SAT.
• Basic knowledge of cGMP, GDP, FDA regulations, and pharmaceutical manufacturing practices.
• Preferred familiarity with Computerized System Validation (CSV) and 21 CFR Part 11.
• Strong technical writing, documentation, analytical, and problem-solving skills.
• Excellent attention to detail and communication skills.
• Fresh graduates and candidates with 0–2 years of relevant experience are encouraged to apply.