Coordinate and lead Computer System Validation (CSV) activities to ensure VWR 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 teams 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.
MAJOR JOB DUTIES AND RESPONSIBILITIES (List in order of importance)
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 disciplines.
Serves as the 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 when necessary, 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.
Expected to stay 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 systems software development lifecycle including system retirement.
Provides value-added 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 relevanceValidation PlanTechnical Documentation (e.g., User Requirement, Functional Requirements, Design Specifications)Requirements of Trace MatrixRisk AssessmentIQ/OQ/PQ Protocols and ReportsValidation 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 systems 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 (Education/Training, Experience and Certifications)
BS/BA Degree in Computer Science, IT, Engineering, Science, or Business
10+ 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.
5+ years of experience in FDA regulated environment with strong knowledge of regulatory compliance pertaining to software validation in IT Infrastructure and Enterprise Systems supporting business, manufacturing, or quality management (e.g., SAP, EtQ, LIMS) plus in-house developed software applications.
KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)
Experience in implementing large systems such as EtQ, LIMS, or SAP.
Strong process knowledge of SAP and its use in a regulated industry.
Demonstrated understanding of FDA Quality System Regulation and ISO/EU standards pertaining to computer software validation (e.g. 21CFR Part 820, Subpart G Production and Process Control, 820.70(i)) software validation/automated processes; 21 CFR Part 11 Electronic Records & Signatures; ISO 13485, 7.5.2 Validation of processes for production and service provision, section 220.127.116.11 General requirements, Eudralex vol 4. Annex 11).
Proven ability of working in a cross functional team environment with excellent leadership, interpersonal and communication skills. Proficient in presenting data to management.
Ability to influence others through persuasive, logical, and constructive debate based on data.
Excellent analytical, prioritization, and multi-tasking skills.
Knowledge and experience utilizing Microsoft Outlook, Word, Excel, and Access, or equivalent software packages.
Knowledge and experience utilizing a laboratory information management system (LIMS) and an Enterprise Resource Planning (ERP) system is preferred.
Excellent attention to detail, follow through, and organizational skills. Ability to advocate a quality environment.
Excellent verbal, written, and interpersonal communication skills.
ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions)
Typically works in an office environment with adequate lighting and ventilation, and a normal range of temperature and noise level.
Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems.
A frequent volume of work and deadlines impose strain on routine basis.
Minimal physical effort is required. Work is mostly sedentary, but does require walking, standing, bending, reaching, lifting, or carrying objects that typically weigh less than 25 lbs.
While performing the duties of this job, the employee is occasionally exposed to fumes or airborne particles, and toxic or caustic chemicals. The noise level in the work environment is usually moderate.
Minimal travel may be required.
DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.
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, or local law.
If you need a reasonable accommodation for any part of the employment process, please contact us by email at ...@avantorinc.com 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.
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