GMP Validation Engineer - Equipment Qualification

CEL-SCI Corporation; Baltimore (MD); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Competitive salaries

Comprehensive benefits

Employee Stock Options

Job summary

A biotechnology firm is seeking a Validation Engineer responsible for regulating, selecting, and maintaining qualification records of equipment and systems. Ideal candidates will have a B.S. in a scientific field and 1-2 years of experience in equipment qualification, with knowledge of GMP and FDA regulations. Responsibilities include authoring protocols, coordinating with departments, preparing reports, and managing deviation activities. Competitive salaries and comprehensive benefits offered.

Qualifications

• 1 to 2 years of equipment qualification/validation experience.

Responsibilities

• Author I/O/PQ protocols and summary reports.
• Maintain equipment periodic review activities.
• Co-ordinate with departments for documentation.
• Assist in specifying and selecting equipment.
• Prepare validation summary reports with recommendations.
• Initiate and maintain Deviation and CAPA activities.

Skills

Knowledge of SOPs

Understanding of GMP and FDA regulations

Experience with Kaye validator and temperature mapping

Technical writing skills

Good communication skills

Root-cause investigation

Cross-functional coordination

Detail-oriented mindset

Education

B.S. in science/engineering

Job description

A biotechnology firm is seeking a Validation Engineer responsible for regulating, selecting, and maintaining qualification records of equipment and systems. Ideal candidates will have a B.S. in a scientific field and 1-2 years of experience in equipment qualification, with knowledge of GMP and FDA regulations. Responsibilities include authoring protocols, coordinating with departments, preparing reports, and managing deviation activities. Competitive salaries and comprehensive benefits offered.