Entry-Level Pharma Validation Engineer (IQ/OQ/PQ)

Virtue America; United States; On-site; USD 65,000 - 90,000; Full time

Job summary

Virtue America is seeking an entry-level Validation Engineer to support qualification, validation, and compliance activities across pharmaceutical manufacturing and biotech operations in the United States.

The role emphasizes IQ/OQ/PQ execution, process and cleaning validation, documentation, and data integrity within a regulated manufacturing environment, offering growth in cGMP/compliance knowledge.

Qualifications

• Bachelor's or Master's degree in Pharmaceutical Sciences, Chemical Engineering, Biotechnology, Biomedical Engineering, Mechanical Engineering, Chemistry or related field.
• Basic understanding of pharmaceutical validation principles and qualification lifecycle.
• Familiarity with IQ, OQ, PQ, process validation and equipment qualification concepts.
• Knowledge of cGMP, GDP, SOPs, and pharmaceutical quality documentation.
• Awareness of risk assessments, deviation management, change control, and CAPA processes.
• Ability to interpret technical documents, equipment specifications, test results, and validation records.
• Strong analytical thinking, problem-solving, organization, and attention to detail.
• Proficiency in Microsoft Word and Excel for protocol preparation, data tracking, and reporting.
• Good written and verbal communication skills with the ability to work across technical teams.
• Preferred: Academic projects, internships, or practical exposure to pharmaceutical manufacturing, laboratory equipment, quality assurance, or validation documentation.

Responsibilities

• Assist with qualification activities for pharmaceutical manufacturing equipment, laboratory instruments, and supporting systems to verify operation per approved specifications.
• Support the preparation and review of validation plans, test protocols, execution records, and final reports under guidance of senior personnel.
• Participate in IQ, OQ, and PQ activities to confirm equipment installation, functionality, and performance.
• Assist with collecting process data, reviewing manufacturing parameters, and documenting evidence that production processes meet requirements.
• Help organize sampling records, review cleaning procedures, and document cleaning validation results.
• Support calibration verification, instrument qualification, and documentation for analytical equipment.
• Assist in identifying validation requirements based on equipment criticality, product quality risks, and intended system use.
• Document deviations and CAPA, assist with investigations, and track corrective actions.
• Help assess proposed equipment, process, and system changes for requalification or revalidation needs.
• Follow cGMP, GDP, SOPs, and regulatory requirements; maintain ALCOA+ data integrity.

Education

Pharmaceutical Sciences

Chemical Engineering

Biotechnology

Biomedical Engineering

Mechanical Engineering

Chemistry

Job description

Virtue America is seeking an entry-level Validation Engineer to support qualification, validation, and compliance activities across pharmaceutical manufacturing and biotech operations in the United States.

The role emphasizes IQ/OQ/PQ execution, process and cleaning validation, documentation, and data integrity within a regulated manufacturing environment, offering growth in cGMP/compliance knowledge.