Senior Validation Engineer

RXinsider LTD.; Conshohocken (Montgomery County); Hybrid; USD 90,000 - 140,000; Full time

Job summary

Cencora is seeking a qualified professional to support computer system validation, ensuring alignment with regulatory standards and company policies. You will lead requirements gathering, design system integration, and prepare comprehensive validation documents across VP, IQ/OQ/PQ, RTM, and VSR, while collaborating with project managers and operations teams.

Proven experience with FDA 21 CFR part 11, GxP, and database validation is required.

Qualifications

• Bachelor’s degree in CS, Engineering or related field
• Five years of experience in electronic document management and validation
• Experience with FDA 21 CFR part 11 and GxP compliance

Responsibilities

• Support computer system validation by aligning operations with requirements and policies.
• Lead gathering of business requirements and system integration design.
• Prepare Validation Protocols, RTM, VMPs, and Validation Reports.
• Interact with cross-functional teams and ensure regulatory compliance.

Skills

SQL queries

Validation testing

GxP compliance

FDA 21 CFR part 11

Documentation management

Education

Bachelor's degree in Computer Science/Engineering

Master's degree in Computer Science/Engineering

Tools

KeatGX

HP Quality Center

Team Foundation Server (TFS)

Microsoft SQL databases

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. #LI-DNI

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

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit https://www.virtualfairhub.com/cencora

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