Validation Engineering

We are the global leader in precision targeting of PRAME , a target expressed in more than 50 cancers. Ourcutting-edgescience and robust clinical pipeline form the broadest PRAME franchise with the most PRAME indications and modalities, spanning TCR T-cell therapies and TCRbispecifics.

We are seeking a Validation Engineer II to lead the implementation of new systems through the validation process and ensure all validation deliverables and regulations have been met. The Validation Engineer II will build and execute a periodic review program for our validated systems.

Monday to Friday; On-site
Reports to :Senior Director, Enterprise Applications
Bachelor’s degree in Science, Engineering or a related major.5+ years experience in the pharmaceutical or biotech industry

Experience working within a GxP regulated manufacturing or laboratory environment.

An understanding of good documentation practices and data integrity principles.

Experience in writing and reviewing deviations and CAPAs, investigations leading to change controls

Draft validation documents including validation plans, user requirements specification (URS), risk assessments, configuration specification documents, installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) protocols, trace matrix and summary reports.

Create and manage project timelines and deliverables.

Monitor and review Quality Management Systems (CAPA, Change Controls, Deviations) and Batch Record Issuance procedures to ensure and maintain compliance with corporate and regulatory agency requirements.

Contribute to the writing, coordination, review, and approval of Quality Events when needed.

Draft SOPs and work instructions for system operation, maintenance, and cleaning.

Assist in Change Control process from initiation, revision of documents and processes up to training and implementation.

Assist in preparing QMS training materials and perform training as required.

Support cross-functional groups for QMS functions and projects not limited to Computer Systems Validation, Equipment Maintenance, Manufacturing, Quality Control, New Hire Onboarding, external and internal audits as needed.

Competitive rates forHealth, Dental, and Vision Insurance

12 company paid holidays

We are an equal opportunity employer and are committed to building a diverse and inclusive workplace. We consider all qualified applicants for employment without regard torace, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexualorientation, gender identity or expression, national origin, ancestry, age, marital status, disability, geneticinformation, veteran status, or any other status protected by applicable law.

We are committed to providing reasonable accommodations to individuals with disabilities and to applicants withsincerely heldreligious beliefs, practices, or observances. If you require assistance or accommodation during the application or interview process, please contact us at View email address on click.appcast.io.