Computer System Validation Engineer
Company: Avantor
Location: Villanova
Posted on: April 10, 2021
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Job Description:
Job SummaryCoordinate 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 ReportRecommends 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
systemQUALIFICATIONS (Education/Training, Experience and
Certifications)BS/BA Degree in Computer Science, IT, Engineering,
Science, or Business5+ 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 7.5.2.1 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.EEO StatementWe 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
TalentManagement@avantorsciences.comand 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.EEO is the LawOFCCP EEO
SupplementPAY TRANSPARENCY NONDISCRIMINATION PROVISION3rd party
non-solicitation policyBy submitting candidates without having been
formally assigned on and contracted for a specific job requisition
by Avantor, or by failing to comply with the Avantor recruitment
process, you forfeit any fee on the submitted candidates,
regardless of your usual terms and conditions. Avantor works with a
preferred supplier list and will take the initiative to engage with
recruitment agencies based on its needs and will not be accepting
any form of solicitationJob InfoType: Full timeLocation: Radnor,
PA
Keywords: Avantor, Philadelphia , Computer System Validation Engineer, IT / Software / Systems , Villanova, Pennsylvania
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