Computer Systems Validation Engineer

We are looking for a Computer Systems Validation Engineer with experience in computer systems validation work with preference to those familiar with MODA and/or Lab Ware interfaces. Technical duties include developing and implementing validation protocols, adhering to domestic and international GMP regulations. It also includes communicating with impact, operating collaboratively while holding themselves and other team members accountable and proactively taking steps to learn & grow based on feedback.

The individual will collaborate with cross‑functional team members such as Quality Systems, Quality Control, Project management and other technical disciplines to lead execution of assigned validation deliverables of the projects.

• Bachelor’s degree in a technical discipline, preferably engineering or biological sciences and a minimum of 5 years pharmaceutical and/or biopharmaceutical industry experience. Corresponding relevant experience in lieu of a bachelor's degree will be considered when assessing candidates.
• Understanding, adhering to and maintaining compliance with cGMP standards is fundamental. Position will navigate complex regulatory requirements to ensure that all changes to LIMS/MODA systems meet industry standards.
• Thorough understanding of cGXPs, GAMP5, S88 and 21
  
  CFR Part 11 (as applicable).
• In-depth knowledge of core principles of validation programs.
• Experience in Trackwise, Veeva, Kneat, ALM or other common electronic documentation systems.