Validation Specialist

Alliance of Professionals & Consultants, Inc.; Raleigh (NC); Hybrid; USD 76,000 - 90,000; Part time

Job summary

Alliance of Professionals & Consultants, Inc. is seeking a Validation Specialist to implement GxP computerized systems for R&D IT. The role requires CSA experience, knowledge of US/EU regulations, and validation of SaaS applications and AI models.

Hybrid role based in Raleigh, NC with 3 days in office. Responsibilities include writing validation documentation, leading stakeholder meetings, and ensuring continued compliance and state of validation across applications.

Qualifications

• GAMP 5 principles and regulatory frameworks (US/EU)
• Experience with CSA and regulatory software assurance
• Understanding of GxP computerized systems validation
• Ability to lead meetings and coordinate with stakeholders

Responsibilities

• Develop and implement validation strategy for GxP systems
• Create validation deliverables: plans, IOUs, changes controls, testing docs
• Lead project activities, train users, drive change management
• Maintain validated state of applications per policies and procedures

Skills

GAMP 5 principles

CSA principles

Regulatory knowledge

GxP software

Education

Bachelor’s Degree in Computer Science / Information Systems

Job description

Job Title: Validation Specialist

Type of Engagement: 6-month contract (Not open to 3rd party C2C consultants. Visa sponsorship is not available)

Work Location: Hybrid position in Raleigh, NC (3 days office)

Job Overview: The Validation Specialist, Regulatory is responsible for implementing GxP computerized systems for the R&D IT department. A successful candidate will have recent CSA experience, an understanding of relevant US and EU regulations, and familiarity with validating SaaS applications, and AI models. Direct experience with electronic Instructions For Use and electronic Prescribing Information, Regulatory Intelligence, and Regulatory Submission and Deficiency management are preferred.

Essential Job Responsibilities:

Validation Strategy

• Subject matter expertise with GAMP 5 principles, US Code of Federal Regulations, and EU Annex 11 regulations
• Subject matter expertise in computer software assurance (CSA) principles
• Ability to review processes and procedures and implement GxP computerized software in a compliant manner
• Ability to lead and facilitate meetings, interact with relevant stakeholders, and build strong relationships

This activity constitutes ~10% of the job description

Technical Writing

• Ability to write validation documents to support the implementation of software applications including change controls, validation plans, user requirements, and testing documentation
• Ability to write training documentation, User and Admin SOPs, as applicable
• Experience with electronic validation applications preferred

This activity constitutes ~40% of the job description

System Implementation

• Ability to implement GxP computerized systems, including project management configuration, user acceptance testing, and hypercare
• Ability to drive user adoption of the new application through training and change management
• Ability to maintain the validated state of applications in accordance with policies and procedures

This activity constitutes ~50% of the job description

Technical & Functional Skills

• Experience with Computer System Validation, Computer Software Assurance and GxP relevant applications
• Experience with writing standard operating procedures, validation deliverables, training material
• Experience running projects and strategy initiatives

Required Skills & Experience:

• Bachelor’s Degree in Computer Science / Information Systems or related discipline
• 3 - 5 years of experience in a position of equal scope and responsibility
• Experience in the pharmaceutical or medical device industry

Big Bonus Points if you Have:

• Experience with Medical Device Regulatory Submissions and applications used by Regulatory Affairs teams
• Experience with CSA validation of SaaS applications
• Experience with CSA or CSV validation of AI models

Job Requisition # 40486 #LI-Hybrid #LI-WC1

A reasonable estimate of the pay range for this role is $55.00 - $65.00 per hour. The disclosed pay range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. The compensation decisions are dependent on the facts and circumstances of each case, such as skills and experience levels.

Meet APC APC is a professional staffing and services organization focused on engaging people and positively impacting lives. As "Professionals serving Professionals"®, we take pride in providing our employees and contractors with the highest level of customer service and support. APC is committed to creating a diverse work environment and is proud to be an Equal Opportunity Employer. All qualified candidates will receive consideration without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, disability, genetics, or veteran status.