Validation Engineer - Cold Chain & Life Sciences Consulting

Cryoport, Inc.; Irvine, Northern (CA, KY); Hybrid; USD 108,000 - 132,000; Full time

Benefits offered by this job

Health insurance

401(k) match

Stock equity

Job summary

Cryoport Systems is seeking a Validation Engineer for Consulting Services to support shipper, packaging, and shipping lane qualifications across temperature-sensitive supply chains. The role involves client discussions, developing validation protocols, and producing technical reports.

Ideal candidates have 2+ years in Biopharma, strong documentation skills, and familiarity with GMP, FDA, ICH guidelines, and ISO/IATA/ISTA standards.

Qualifications

• BA/BS in Life Sciences or related field preferred.
• 2+ years in Biopharma/Medical Device, Cell & Gene Therapies preferred.
• 2+ years writing professional customer-facing documentation.
• Experience with ISO, IATA, ASTM, ISTA standards preferred.
• Equipment and Process Validation (DQ/IQ/OQ/PQ) preferred.
• Knowledge of cGMP, FDA and ICH guidelines preferred.
• Strong Excel skills: Pivot tables, graphs, analytics.
• Proficient with Microsoft Office (Word, Excel, PowerPoint, Teams).
• Project management skills desirable.

Responsibilities

• Oversee validation procedures and create protocols and reports.
• Coordinate shipping lane qualifications and testing activities.
• Collaborate with clients and internal teams to deliver validated solutions.
• Improve protocols and reporting for validation activities.

Skills

Biopharma experience

Documentation writing

Data analysis

Excel proficiency

Communication

Project management

Education

BA/BS Life Sciences

Regulatory knowledge

Tools

Excel

PowerPoint

Office Suite

Job description

Cryoport Systems is seeking a Validation Engineer for Consulting Services to support shipper, packaging, and shipping lane qualifications across temperature-sensitive supply chains. The role involves client discussions, developing validation protocols, and producing technical reports.

Ideal candidates have 2+ years in Biopharma, strong documentation skills, and familiarity with GMP, FDA, ICH guidelines, and ISO/IATA/ISTA standards.