Validation Engineer

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 a comprehensive supply chain partner for the life sciences industry, delivering specialized solutions to meet the challenges of the biopharmaceutical, cell and gene therapy, reproductive medicine, and animal health markets. Our offerings span logistics, BioServices and biostorage, cryopreservation, and consulting, ensuring the highest standards of quality and reliability for sensitive materials. With our expansive platform of management solutions and decades of temperature-controlled supply chain expertise, Cryoport Systems helps Enable the Outcome™ by supporting certainty and precision in the supply chain, whether advancing groundbreaking therapies, supporting families on their reproductive journeys, or enhancing animal health programs.

POSITION SUMMARY

• Participate and oversee internal Consulting Services qualification processes including:
• Assist in the development of validation procedures.
• Perform internal validations including 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’ 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.
• Assists 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 utilized 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 ñ written and verbal.
• Analytical thinker with proficient skills 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, Power Point, 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.

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 (Nasdaq: CYRX).