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Computer Systems Validation Engineer (Remote)

at VWR International, LLC in WilmingtonWilmington, Delaware, United States

Job Description

Job Summary
Coordinate and lead Computer System Validation (CSV) activities to ensure Avantor computerized and automation systems are in full compliance with regulatory requirements, company policies, and procedures. Serve as the subject matter expert to provide compliance leadership and oversight to cross-functional team's Computer System Validation (CSV) projects. Collaborate with business partners to maintain and improve CSV processes to ensure robust, efficient, and compliant processes. Serve as the Systems CSV contact to management and business partners involved in CSV projects. Implement and monitor test scripts to assess functionality, reliability, performance, and quality of the service or product. Identify and remedy defects within the production process.

***Proficient SAP Validation Experience irequired

MAJOR JOB DUTIES AND RESPONSIBILITIES:
Responsible for developing the CSV roadmap and further policy for present and future VWR IT Infrastructures.
Interface effectively with management personnel in IT, Engineering, Quality, R&D, and other technical fields.
Act as lead SME for CSV projects; including inquiries pertaining to the interpretation of FDA, EU, and other regulatory requirements for computer system validation.
Provides management with updates on projects, the health of the CSV process, and communicates risk-based issue escalations.
Provide technical decision making regarding validation strategies and requirements for projects.
Strong understanding of IT network infrastructure and required qualification activities.
Remain current with US and international regulations, industry standards, and emerging topics (e.g., cybersecurity) pertaining to computer software validation.
Provides compliant and pragmatic leadership to software validation projects throughout the computer system's software development lifecycle including system retirement.
Provides valuable guidance during the design, deployment, maintenance, and retirement of IT computer system. This guidance applies to all systems developed in house, developed by contractors, and off the shelf (OTS) software. May perform supplemental research to provide options for compliant solutions to barriers encountered during validation activities.
Reviews and approves software validation documentation to ensure documentation is compliant with IT procedures and all applicable quality system regulations or standards.
Organizes or conducts training on software validation principles and Part 11 requirements.
Exercises judgment in selecting methods and language to provide compliant solutions to address and document issues, which may arise during validation activities.
Prepare, review, and approve various computer validation documents for CSV projects including the following:
Regulatory Assessment for determination of GxP and Part 11 relevance
Validation Plan
Technical Documentation (e.g., User Requirement, Functional Requirements, Design Specifications)
Requirements of Trace Matrix
Risk Assessment
IQ/OQ/PQ Protocols and Reports
Validation Summary Report
Recommends and/or drives continuous improvement activities to streamline validation processes. Leads or supports CSV remediation activities.
Serves as the CSV SME for internal and external audits.
Ensures that the system's validation state is maintained through proper testing as part of the change control program and re-validation as necessary. Performs a periodic review of systems to monitor the validation status of the system

QUALIFICATIONS:
BS/BA Degree in Computer Science, IT, Engineering, Science, or Business
3-5 years of experience within a dedicated CSV or product software validation role. Proficient in system and software validation engineering processes, software risk management, software V&V methodologies, and software configuration management.
Proficient SAP Validation Experience required
3-5 years of experience in FDA regulated environment with strong knowledge of... For full info follow application link.

We are an Equal Employment/Affirmative Action employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

For more information about equal employment opportunity protections, please view the Equal Employment Opportunity is THE LAW Poster, EEO is the Law Poster Supplement, and Pay Transparency Non-Discrimination Provision using the links below.

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Job Posting: 1020429

Posted On: Aug 14, 2022

Updated On: Sep 13, 2022