Validation Engineer - External Operations - FM12


Full-time

Menlo Park, California, United States

Cell Therapy Operations

Location: Orchard North America, Menlo Park, CA

Reporting to: Senior Engineer, Cell Therapy Operations

Summary

The Validation Engineer - External Operations is responsible for the design, development, qualification and maintenance of secondary/tertiary global packaging and distribution solutions, and warehouse support for clinical and commercial cell and gene therapy-based products. This person will be a key member on project teams to support external operations and global supply chain to deliver high-quality packaging and shipping operations, and warehouse support on schedule, which meets customer, business, technical and regulatory needs.

This person will promote standardization and compatibility between in-house and contract packaging facilities. The successful candidate will have effective collaborations with internal and external stakeholders.

Responsibilities

Packaging and Shipping Operations

  • Lead and support all qualification activities pertaining to drug substance, vector and drug product packaging and shipping operations both in-house and CMOs.
  • Lead risk-based approach to qualification efforts for on-site implementation of changes and packaging-related launch activities.
  • Perform investigations associated with deviations, CAPAs and other OOS trends associated with packaging and shipping operations.
  • Evaluate new packaging process or packaging to increase productivity and/or reduce costs without sacrificing quality.
  • Author/Review SOPs, work procedures, specifications, design and qualification protocols, and support testing of the packaging components, packaging systems and associated shipping attributes.
  • Participate in new vendor/supplier packaging and shipping RFPs, review associated qualification data and draft suitable summary reports in compliance with US and Europe regulations.
  • Work with Global Distribution and Supply Chain group to support commissioning, qualification and validation projects related to external operations.

Other Operations

  • Execute qualification efforts for packaging and labeling (P&L) equipment, environmental transport vehicles and storage chambers/rooms on an as need basis.
  • Participate and contribute in design development, commissioning planning and execution, and turnover of systems for warehouse facility.

Requirements

Experience

Require B S in a technical discipline with minimum 5 years of validation in packaging, shipping and thermal operations in the Biotech/Pharmaceutical industry.

Demonstrated Skills:

  • Excellent organizational and communication skills with an ability to multi-task and manage timelines
  • Experience working with and knowledge of ISO and ASTM packaging test protocols
  • Working knowledge of packaging manufacturing processes
  • Proficient in MS Office: Word, Excel, Outlook, PowerPoint
  • Knowledge and experience of testing methods including CCI, ISTA, ASTM
  • Excellent written and verbal communication skills.

Cultural and Behavioural Attributes

  • Candidate must have a team mindset and be capable of building alliances internally and externally across disciplines.
  • Must be able to set a positive tone when faced with setbacks and challenges bringing potential solutions to the table.
  • Must be dedicated and committed to improve the lives of patients.
  • Must respect and embrace diversity of people, ideas and culture
  • Must be able to lead by example.