Validation Engineer - Biopharma & GMP Compliance

Cryoport Systems; Irvine (CA); On-site; USD 105,000 - 135,000; Full time

Benefits offered by this job

Health insurance

Stock options

401k with company match

Job summary

Cryoport Systems is seeking support for Consulting Services qualification activities in the life sciences supply chain. You will help develop validation procedures, prepare equipment, and document test results while coordinating with internal teams and external testing labs.

Responsibilities include creating project plans for shipping lane qualifications, packaging configurations, and qualification testing. Strong communication and meticulous documentation are essential to drive client success.

Qualifications

• BA/BS in Life Sciences, Biopharma or related healthcare field preferred but not required.
• 2+ years in Biopharmaceuticals or Medical Device industry, Cell & Gene Therapies preferred.
• Experience writing professional documentation with customer-facing materials.

Responsibilities

• Oversee Consulting Services qualification processes.
• Assist in developing validation procedures and reports.
• Perform internal validations and document test results.
• Support project creation for shipping lane qualifications and systemized qualifications.
• Coordinate with external labs to ensure protocol execution and timelines.
• Engage clients in validation plan discussions and present results.
• Develop customer-centric, quality-driven protocols.

Skills

Attention to detail

Communication skills

Analytical thinking

Organization

Team collaboration

Self-motivation

Education

BA/BS in Life Sciences/Biopharma or healthcare field

Tools

Excel

Pivot tables

Microsoft Office

Job description

Cryoport Systems is seeking support for Consulting Services qualification activities in the life sciences supply chain. You will help develop validation procedures, prepare equipment, and document test results while coordinating with internal teams and external testing labs.

Responsibilities include creating project plans for shipping lane qualifications, packaging configurations, and qualification testing. Strong communication and meticulous documentation are essential to drive client success.