Computer Systems Validation Lead

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Company: Thermo Fisher Scientific Inc.

Location: Cambridge

Posted on: September 12, 2020

Job Description:

location Cambridge, Massachusetts, US Job ID: 120898BR

Thermo Fisher Scientific’s Viral Vector Services (VVS) is arapidly growing, dynamic gene therapy Contract Development andManufacturing Organization (CDMO) that is seeking sharp individualsto bring the highest quality processes, products and testing to ourclients. Our employees are committed to making a difference in ourorganization, for our client partners and the patients we serve. Weare looking for top talent with proven competencies and strongcharacter to join our team and help lead our organization into thefuture.

Location: Cambridge

How will you make an Impact:

The Computer Systems Validation Lead will be responsible foroversight of all GxP-Regulated Computerized Systems at allapplicable points of the computerized system lifecycle, ensuringcompliance with regulatory requirements, company Computer SystemsValidation (CSV) and Lifecycle procedures, and Data Integrityrequirements. This individual will provide oversight of validationactivities, lead the development and approval of validationdocumentation, risk assessments, work with project teams todetermine which elements should be validated, and conduct impactassessments of proposed changes to computerized systems. Theincumbent will provide the necessary oversight of system relatedissues, employ risk-based methodology, and ensure that all GxPcomputerized systems are maintained in a validated state throughouttheir lifecycle. Additionally, the individual will focus onensuring consistent policy administration, implementing keyimprovement initiatives and solving compliance issues.

What will you do:

Provide oversight of all GxP Computerized Systems, including ITand Automation systems, QC software, and IT infrastructure.

Develop and approve system lifecycle documentation to ensurethat procedures and methodologies are followed, and thatappropriate and complete documentation is captured and reported tosupport CSV activities for assigned systems, including associatedchange requests.

Maintain GxP computerized system inventory list.

Represent IT Quality on all assigned projects in support of CSVactivities.

Consult on conformance of validation strategies and lifecycledeliverables to current regulatory requirements and companyprocedures.

Provide timely and proactive support and guidance to IT andautomation personnel in their System Development Lifecycle (SDLC)efforts to facilitate project timelines.

Provide IT quality oversight of system-related issues.

Employ risk-based methodology, where feasible andachievable.

Escalate any potential compliance issues in a timely manner.

Lead or support the development of procedures, workinstructions, validation templates and training materials to ensurethat the control of GxP computerized systems is integrated intoQuality Management System.

Support internal and client audits and regulatoryinspections.

Provide support in other quality system related activitiesincluding quality exceptions and change control.

How will you get here:

BA/BS required in Life Sciences or IT related discipline with 5years of appropriate work experience.

3+ or more years working in a Quality role desired. LifeSciences biotech / pharmaceutical experience required.

Knowledge of IT Control methodologies, including GAMP5 and solidunderstanding of GxP guidance, including 21 CFR Part 11, Annex 11and Data Integrity.

Knowledge of the computerized system lifecycle activities, CSVand IT controls in a regulated environment.

Experience with system validation across GxP landscape,specifically GMP applications.

Strong communication skills, both verbal and written.

Ability to work both independently and with teams at variouslevels in the organization.

Ability to work in a very dynamic environment with a clear senseof urgency.

Excellent organizational skills and attention to detail andaccuracy.

Experience supporting health authority inspections a plus.

Strong computer skills including Microsoft Word, Excel, andAccess.

At Thermo Fisher Scientific, each one of our 75,000extraordinary minds has a unique story to tell. Join us andcontribute to our singular mission—enabling our customers to makethe world healthier, cleaner, and safer.

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Thermo Fisher Scientific Inc. is the world leader in servingscience, with annual revenue exceeding $25 billion. Our Mission isto enable our customers to make the world healthier, cleaner andsafer. Whether our customers are accelerating life sciencesresearch, solving complex analytical challenges, improving patientdiagnostics and therapies or increasing productivity in theirlaboratories, we are here to support them. Our global team of morethan 75,000 colleagues delivers an unrivaled combination ofinnovative technologies, purchasing convenience and pharmaceuticalservices through our industry-leading brands, including ThermoScientific, Applied Biosystems, Invitrogen, Fisher Scientific,Unity Lab Services and Patheon. For more information, please visitwww.thermofisher.com .

Thermo Fisher Scientific is an Equal Opportunity Employer. Allqualified applicants will receive consideration for employmentwithout regard to race, creed, religion, color, national or ethnicorigin, citizenship, sex, sexual orientation, gender identity andexpression, genetic information, veteran status, age or disabilitystatus.

Keywords: Thermo Fisher Scientific Inc., Cambridge , Computer Systems Validation Lead, Other , Cambridge, Massachusetts

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Keywords: Amazon Workforce Staffing, Cambridge , Computer Systems Validation Lead, Other , Cambridge, Massachusetts