Validation Engineer

Cryoport Systems, LLC; Irvine (CA); On-site; USD 108,000 - 132,000; Full time

Benefits offered by this job

Health insurance

401K match

Stock equity

Job summary

Cryoport Systems, LLC is seeking a Validation Engineer - Consulting Services to support client-facing qualifications across temperature-sensitive supply chains. The role includes engaging in client discussions, managing qualifications, and developing technical reports.

The ideal candidate should possess a BA/BS degree and have 2+ years in the Biopharma industry, with strong analytical and communication skills. Benefits include health insurance, 401K match, and stock options.

Qualifications

• 2+ years of experience in Biopharmaceuticals or Medical Device Industry.
• Experience in writing professional documentation.
• Preferred experience with ISO, IATA, ASTM and ISTA standards.

Responsibilities

• Oversee internal Consulting Services qualification processes.
• Perform internal validations and document results.
• Manage qualification activities for client-related projects.

Skills

Attention to detail

Strong communication skills

Analytical thinking

Organizational skills

Team collaboration

Self-motivated

Education

BA/BS degree in Life Sciences/Biopharma

Tools

Microsoft Office

Excel

Job description

Position Summary

The Validation Engineer - Consulting Services will support the Consulting Services team’s offerings around shipper, packaging, and shipping lane qualifications across temperature sensitive supply chains. This is a client‑facing role within the Cryoport Systems Consulting Services department that is responsible for engaging in client discussions, performing qualifications, and developing technical reports.

Primary Responsibilities

• Participate and oversee internal Consulting Services qualification processes including development of validation procedures.
• Perform internal validations by developing validation protocols and reports, preparing equipment, and documenting & analyzing test results.
• Support project creations for shipping lane qualifications, packaging configurations, systemized operational qualifications (physical and/or thermal performance testing), and shipping feasibility studies.
• Manage qualification activities for Consulting Services’ client‑related projects.
• Work as a team with all Consulting Services team members.
• Engage with clients presenting validation plans in client collaboration meetings.
• Develop and customize customer‑centric quality‑driven protocols.
• Assist with coordination between external third‑party testing laboratories to ensure protocol execution, timelines, and quality metrics are achieved.
• Evaluate, document, and articulate client‑specific results utilizing strong communication skills.
• Assist in optimizing existing protocols, processes, and reporting for all validation activities.
• Engage in continuous process improvement areas within Cryoport Systems Consulting Services.
• Support cross‑organizational departments as needed.

Competencies & Personal Attributes

• Professional with high attention to detail who focuses on client success.
• Strong communication skills – written and verbal.
• Analytical thinker with proficiency in math, statistics, and data analysis applications.
• Strong organizational skills to manage multiple projects within overlapping timeframes.
• Team player with ability to manage internal and external teams to achieve deliverables.
• Self‑motivated with initiative to self‑learn to fill in knowledge gaps and expand contributions.

Qualifications and Education Requirements

• BA/BS degree (in Life Sciences/Biopharma or a related healthcare field is highly preferred but not required).
• 2+ years of experience in Biopharmaceuticals, Medical Device Industry (specifically Cell & Gene Therapies is highly preferred).
• 2+ Years of Experience in writing professional documentation with customer‑facing materials.
• Preferred experience with ISO, IATA, ASTM and ISTA standards relating to the pharmaceutical supply chain.
• Preferred experience with Equipment and Process Validation using DQ, IQ, OQ, and PQ.
• Knowledge of cGMP requirements, FDA and ICH guidelines is highly preferred.
• Experience using Excel, creating pivot tables, graphs and customer digestible and meaningful visual and tabular analytics.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Teams).
• Project Management skills/training is desirable.

Preferred Skills

• Understanding of Cold Chain and temperature‑sensitive logistics, Packaging testing and qualification (GDP).
• Good Distribution Practices (USP 36 – Chapter 1079, Good Storage and Distribution Practices for Drug Products).
• ISO 21973 Biotechnology General requirements for transportation of cells for therapeutic use.
• 21CFR Part 210 cGMP in Manufacturing, Processing, Packing, or Holding of Drugs.
• 21CFR Part 211 cGMP for Finished Pharmaceuticals.

Compensation

Up to $120,000 depending on experience + bonus, stock, 401k match, benefits, etc.

Benefits

Health insurance, a 401K with company match, and stock equity (Nasdaq: CYRX).

Equal Opportunity Employer

Cryoport Systems is an Equal Opportunity Employer offering competitive compensation with a generous benefits package that includes health insurance, a 401K with company match and stock equity.