Senior Validation Engineer

Cencora; United States; Remote; USD 120,000 - 150,000; Full time

Benefits offered by this job

Medical

Dental

Vision care

Paid parental leave

Professional development resources

Job summary

Cencora is seeking a senior validation specialist to support computer system validation and ensure alignment with regulatory requirements. You will lead the gathering of business requirements, design system integrations, and prepare critical validation documents while collaborating with cross-functional teams.

The role requires expertise in EDMS, SQL data verification, and GxP compliance, with fully remote work available for qualified candidates.

Qualifications

• Bachelor’s degree in Computer Science, Engineering or related field.
• 5+ years experience in electronic validation and compliance.
• Experience with FDA 21 CFR Part 11 and GxP requirements.

Responsibilities

• Support computer system validation aligning with requirements and regulations.
• Lead gathering of business requirements and design for system integration.
• Prepare Validation Protocols, RTM, VMPs, and VSRs; manage change control.

Skills

EDMS experience

SQL querying

Validation planning

GxP compliance

Education

Bachelor's degree in Computer Science/Engineering

Master’s degree in related field

Tools

KeatGX

HP Quality Center

TFS / Team Foundation Server

Job description

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere.

Job Details

Primary Duties & Responsibilities:

Support the computer system validation process by ensuring alignment of operations with system requirements, corporate policies, industry standards, and applicable regulation. Lead in the gathering of business requirements and system integration design, identifying gaps in software, conducting effective risk assessments, evaluating mitigation strategies, execution of validation testing, defect resolution and completion of validation deliverables. Prepare Electronic Document Management Systems and any configuration management tools. Prepare, execute, and analyze Validation Protocols such as validation plan (VP), BRD, IQ/OQ/PQ protocols, Requirement Traceability Matrix (RTM), Release Memo, and Validation Summary Reports (VSR); Interact with cross functional teams comprised of project managers, business and portfolio owners and business operations. Utilize systems compliance with FDA 21 CFR part 11 and cGxP; Write queries in SQL, SQL database, or Microsoft relational databases to verify data in the pharmaceutical healthcare industry. Test documentation and management systems for HP Quality center with Team Foundation Server (TFS). Generate and revise Validation Master Plans (VMPs), Qualification Protocols (IQ/OQ/PQ), Trace Matrices (RTM), Test Plans, Risk Assessment (RA), Final Summary Reports (VSR), and Change Control by providing instructions and scientific rationale for the performance of validation studies. Perform post-execution review of test case for completeness, accuracy and adherence to policies and procedures. Provide technical decision-making regarding validation strategies for complex projects. Maintain accountability for training validation test team on validation methods.

Qualifications :

Requires a Bachelor’s degree (or foreign equivalent) in Computer Science, Engineering (any) or a related discipline, plus five years of experience with: (1) Electronic Document Management Systems; (ii) prepare, execute, and analyze Validation Protocols including validation plan, BRD, IQ/OQ/PQ protocols, Requirement Traceability Matrix, Release Memo, and Validation Summary Reports. (Employer will also accept a Master’s degree in the same fields and three years of experience) Experience must include: experience in the pharmaceutical healthcare industry utilizing systems compliance with FDA 21 CFR part 11 and GxP (GCP and GDP); writing queries in Microsoft relational databases to verify data, utilizing KeatGX for test documentation and executions tracking and reporting defects. Fully remote work available.

What Cencora offers

• medical
• dental
• vision care
• backup dependent care
• adoption assistance
• infertility coverage
• family building support
• behavioral health solutions
• paid parental leave
• paid caregiver leave
• variety of training programs
• professional development resources
• opportunities to participate in mentorship programs
• employee resource groups
• volunteer activities
• For details, visit https://www.virtualfairhub.com/cencora

Full time

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [e-mail]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Affiliated Companies

Affiliated Companies: AmerisourceBergen Services Corporation