Validation Engineer

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

Overview

The Validation Engineer is responsible for the regulation and support of equipment and systems. Assists in equipment selection, specification, and negotiating fees. Maintains all records related to qualification and validation. Works on projects where data analysis requires evaluation of defined factors to broad concepts. Utilizes independent judgment within broad parameters to determine an appropriate solution. Prepares validation reports, suggests and assists in determining specifications, and makes recommendations for modifications as necessary. The Validation Engineer reports to the Validation Supervisor.

Education/Experience

• B.S. in science/engineering field and 1 to 2 years of equipment qualification/validation experience

Skills/Abilities

• Ability to understand and demonstrate knowledge of Standard Operating Procedures (SOPs).
• Demonstrates knowledge of Good Manufacturing Practice (GMP) and FDA 21 CFR 210/211/820, EU GMP Annex 1, ICH guidelines.
• Hands-on experience with Kaye validator and temperature mapping.
• Soft skills such as technical writing, good communication skills, root-cause investigation and cross-functional coordination skills, detail-oriented mindset.

Responsibilities

• Author I/O/PQ protocols, periodic review documents, specifications, SOPs and summary reports.
• Maintain and execute equipment periodic review activities for various departments equipment and systems including Facilities, Environmental Monitoring, Bioassay, Manufacturing and Quality Control.
• Co-ordinate with various departments and stakeholders to gather information and documentation related to the equipment and systems.
• Assist in specifying and selecting equipment. Maintains all records related to qualification and validation.
• Prepare periodic review and validation summary reports and make recommendations for modifications as necessary.
• Initiate and maintain Deviation and CAPA activities and perform any corrective actions as needed.

Work Hours

Position is full time.

This position may require periodic local travel between CEL-SCI Facilities, to contract facilities, and to external Validation providers.

Location

Baltimore & Elkridge, MD

Compensation & Benefits

We offer competitive salaries, outstanding comprehensive benefits, and Employee Stock Options.

Please submit cv/resume and cover letter to [e-mail]. Reference the job title in the subject line of the email

Disclaimer

CEL-SCI Corporation is committed to a policy of equal employment opportunity. CEL-SCI will recruit, hire, train, and promote into all job titles the most qualified individuals, without regard to race, color, creed, protected veteran status or disability, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.