GMP Validation Engineer – Cell Therapy

Cellipont Bioservices; Silver Spring (MD); Vor Ort; USD 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

401K match

Tuition Reimbursement

Flexible work schedules

PTO and holidays

Zusammenfassung

Cellipont Bioservices is seeking a Validation Engineer to join the Validation team in Maryland. You will support GMP validation projects for equipment, utilities, facilities, processes, and computerized systems, and collaborate with contractors to review validation lifecycle documentation for GMP use.

The role involves developing and executing qualification studies, ensuring data integrity per 21 CFR Part 11, and maturing the validation program within a cGMP cell therapy facility.

Qualifikationen

• Bachelor's Degree with 1+ years of cGMP experience in Pharmaceutical/Life Sciences
• Master's Degree is a plus
• Experience in qualification of cell therapy equipment and cGMP environment is a plus
• Excellent interpersonal skills with experience dealing with a diverse workforce
• Strong multi-tasking ability and organizational skills
• Able to work independently with minimal supervision and be proactive

Aufgaben

• Support GMP validation projects of low to medium complexity alongside in-house and contracted resources
• Oversee qualification activities in cGMP validation best practices
• Develop qualification and validation protocols, execute studies, analyze data, and develop final reports
• Support validation deviation investigations and determine assignable causes
• Review validation lifecycle documentation including requirements, specifications, protocols, and reports
• Understand FDA 21 CFR Part 11 Data Integrity and apply it to validation activities

Kenntnisse

Interpersonal skills

Multitasking

Organizational skills

Attention to detail

Communication skills

Ausbildung

Bachelor's Degree in Life Sciences or related

Master's Degree

Tools

Microsoft Office Suite

Jobbeschreibung

Cellipont Bioservices is seeking a Validation Engineer to join the Validation team in Maryland. You will support GMP validation projects for equipment, utilities, facilities, processes, and computerized systems, and collaborate with contractors to review validation lifecycle documentation for GMP use.

The role involves developing and executing qualification studies, ensuring data integrity per 21 CFR Part 11, and maturing the validation program within a cGMP cell therapy facility.