Senior Validation Engineer

Cryoport Systems•Irvine, CA

3d•$140,000

About The Position

Client-facing role within Cryoport Systems Consulting Services department that is responsible for receiving and assimilating client information, assembling requests & requirements, and formulating solutions for new and existing Cryoport Systems clients. The Senior Validation Engineer will focus on client engagement, development of processes and tools to support Consulting Services offerings around shipper / product qualifications as well as other projects primarily supporting biopharmaceutical and cell and gene therapy clients.

Requirements

Professional with high attention to detail who focuses on client success.
Strong Communication Skills – 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.
Excellent listening and presentation skills
Creative thinker and great problem solver
BA/BS degree (in Life Sciences/Biopharma or a related healthcare field is highly preferred but not required – advanced degree is a plus)
5+ Years of Experience in Biopharmaceuticals, Medical Device Industry (specifically Cell & Gene Therapies is highly preferred)
Preferred experience with Equipment and Process Validation using DQ, IQ, OQ, and PQ.
Knowledge of cGMP requirements, FDA and ICH guidelines is highly preferred
Familiarity with FMEA, DOE, DMAIC, 5S, Lean Manufacturing, Design for Manufacturing (DFM)/Design for Assembly (DFA) tools and methods are a plus.
3+ Years of Experience in writing professional documentation with customer facing materials
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

Nice To Haves

Preferred experience in the pharmaceutical cold-chain packaging and validation experience – including custom packaging and accessory design, testing, and validation (including familiarity with ISO, IATA, ASTM and ISTA standards relating to the pharmaceutical supply chain)
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.

Responsibilities

Participate and oversee internal Consulting Services qualification/validation processes including:
Assist in the development of validation standards and procedures.
Perform internal validations for equipment, new products, and facilities by developing validation protocol & reports, preparing equipment, and documenting & analyzing test results.
Manage qualification activities for Cryoport Systems’ Consulting Services client related projects.
Work as a team with all Consulting Services team members.
Engage with clients by presenting validation plans and participating in client collaboration meetings.
Develop and customize customer centric quality driven protocols.
Coordinate and conduct training for qualification activities, requirements, and procedure for all appropriate department stakeholders.
Execute and monitor client approved protocol with a high degree of oversight ensuring activities, chain of custody, and compliance management are met.
Assisting 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.
Serve as a Subject Matter Expert (SME) for the Consulting Validation Engineering group by:
Ability to quickly access client requests and needs.
Leading Client facing interactions to better understand challenges, creating solutions, and resolving potential impediments.
Engage in continuous process improvement areas within Cryoport Systems Consulting Services
Support cross-organizational departments as needed:
Perform FMEA risk assessment and determine risk mitigation strategies.
Support Supplier Evaluation and Monitoring program
Evaluate change control requests for potential for revalidation requirements.
Provide technical support during non-conforming material, customer complaint, deviation investigations, and assist in the determination of appropriate CAPA, if applicable
Provide budget requirements and monitor expenses to budget.