Senior Validation Specialist

Overview

As a Validation Specialist, you will be responsible for supporting the validation lifecycle and ongoing compliance activities for computerized GxP systems used across the organization. This includes risk assessments, validation testing, change control support, audit inspection and compliance.  

Responsibilities

• Work closely with QA, IT, External Vendors & System Owners 

• Support development and implementation of risk-based validation framework for AI enabled GxP systems 

• Support validation activities for GxP computerized systems, including system period reviews 

• Track and manage validation deviations and defections through to closure 

• Support Internal Audits and regulatory inspections 

• Support updates to SOPs, work instructions and validation templates 

Qualifications

• Experience working within a clinical trials environment (CRO, pharma or academia) 

• Understanding computer system validation (CSV) principles 

• Familiar with CFR p11, Annex 11, EU AI ACT, ALCOA+ and ICH GCP 

About Phastar 

 

Phastar is an award-winning biometrics and data science CRO, trusted by pharma, biotech, and medical device companies worldwide. With a global team of data specialists, we bring expertise, precision, and pace to every trial, because behind every data point is a patient waiting for treatment. 

We transform complex data into clear, actionable intelligence, helping accelerate drug development, and bring life-changing therapies to patients faster. 

 

 

Awards & Recognition 

• SCRIP – Best Contract Research Organization, Specialist Provider 

• Citeline – 2025 Award Winner 

• Fierce CRO Awards – Recognized Industry Leader 

 

Apply Now 

 

Be part of a team known for technical expertise, quality, and impact. We value Excellence, Collaboration, Integrity, Innovation, and Passion—and we seek team members who embody these qualities. Apply today! 

 

Phastar is committed to the principles and practices of equal opportunities and to encourage the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, color, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all. 

 

Important notice to Employment businesses/Agencies 

 

Phastar does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Phastar's Head of Talent Acquisition to obtain prior written authorization before referring any candidates to Phastar. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Phastar. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Phastar. Phastar shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.