Lead Validation Specialist

Theradex Oncology•Princeton, NJ

14d•$125,000 - $150,000•Hybrid

About The Position

As part of Theradex Oncology, you will have the opportunity to work with one of the largest professional teams focused solely on the development of cancer therapies. Cancer research continues to evolve as new therapies and therapeutic approaches are discovered, as part of the team you will work to support our sponsors in the development of these therapies. Theradex Oncology is an environment for highly motivated individuals who want to make a difference. Opportunity Lead Validation Specialist Location: Princeton NJ and Remote – Preference given to applicants residing in the East Coast. We are seeking an experienced Senior Validation Specialist with experience in clinical systems to join our team. I n this role, you will provide project leadership for the validation team and be responsible for ensuring that clinical systems are validated and maintained in compliance with GxP regulations and 21 CFR Part 11. You’ll work cross-functionally with validation, developers and SMEs to support rapid development timelines while upholding regulatory standards. You’ll be responsible for creating, executing, and maintaining validation strategies and documentation where scope and requirements can shift quickly. This is an ideal opportunity for someone who thrives in fast-paced, dynamic environments where adaptability, critical thinking, and initiative are essential.

Requirements

Bachelor’s degree
8+ years prior experience inclusive of computer systems validation
5+ Years relevant experience in Leading a Validation Team
Strong experience working with relational databases ( Oracle, MS SQL ) to ensure data integrity in compliance with ALCOA+
Knowledge and understanding of Regulatory Guidelines for the use of computer systems
Experience working with GxP regulations and 21 CFR Part 11
Experience mentoring and coaching teams
Prior experience working in a Life Science regulated industry
Computer Systems and Technology: Strong knowledge of computer systems validation (SDLC, Agile methodologies) web technology, and cloud-based systems and proficiency with Computer skills including advanced knowledge of excel (e.g. Microsoft Word, Excel spreadsheets, PowerPoint, SQL)
Analytical and Problem-Solving Skills: Ability to research, analyze system requirements, develop alternatives, and implement solutions
Communication and Interpersonal Skills: Strong verbal and written communication skills as well the ability to work both independently and with cross-functional teams
Time Management Skills: Highly organized, result-oriented, and a self-starter comfortable working in fast-paced environment with evolving priorities
Able to work effectively as an onsite or remote worker
Must be highly fluent in English
Willing to travel to meetings in Princeton, NJ as needed. Advance notice will be provided

Nice To Haves

Prior project management experience, preferred

Responsibilities

Provide project leadership for the validation team
Ensuring that clinical systems are validated and maintained in compliance with GxP regulations and 21 CFR Part 11
Creating, executing, and maintaining validation strategies and documentation where scope and requirements can shift quickly