CambridgeRecruiter Since 2001
the smart solution for Cambridge jobs

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.

To access this job later or share with a friend, please enterName and Email Address below.

Your Name

Get notified for similar jobs Sign up and receive similar jobalerts to your email

Enter Email address

Get customized job recommendations based on your career area ofinterest. How would you rate your experience popup

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

Didn't find what you're looking for? Search again! Other Other Jobs

Amazon Warehouse Operator (Full-Time) - Day and Night Shifts Available - Up to$1000 sign on Bonus +

Description: Seasonal Full-time Warehouse Team Member - 1000 sign-on bonus Hourly pay rate: Earn 15.25 - 18.25/hr, plus benefits and a 1,000 sign-on bonus. Limited Time Opportunity Location: Milford, (more...)

Company: 8162

Location: Woonsocket

Posted on: 09/15/2020

Warehouser - Earn $15.25/hr or more, plus benefits and a $1,000 sign-on bonus

Description: Seasonal Full-time Warehouse Team Member - 1000 sign-on bonus Hourly pay rate: Earn 15.25 - 18.25/hr, plus benefits and a 1,000 sign-on bonus. Limited Time Opportunity Location: Milford, (more...)

Company: 8162

Location: Woonsocket

Posted on: 09/15/2020

Amazon Workforce Staffing: Order Fulfillment Team Member

Description: Warehouse Team Member Seasonal, Part-Time, Full-Time, Flexible Hours Shifts: Overnight, Sunrise, Day, Evening, WeekendLocation Fall River, MAJob opportunities vary by location. We update postings

Company: Amazon Workforce Staffing

Location: Woonsocket

Posted on: 09/15/2020

Warehouser (Weekend/Weekday Shifts Available) - Up to $1000 sign on Bonus +Benefits

Description: Seasonal Full-time Warehouse Team Member - 1000 sign-on bonus Hourly pay rate: Earn 15.25 - 18.25/hr, plus benefits and a 1,000 sign-on bonus. Limited Time Opportunity Location: Milford, (more...)

Company: 8162

Location: Woonsocket

Posted on: 09/15/2020

Amazon Workforce Staffing: Full-Time Amazon Package Sorter With Sign-On Bonus

Description: Seasonal Full-time Warehouse Team Member 1000 sign-on bonusHourly pay rate:Earn 15.25/hr or more, plus benefits and a 1,000 sign-on bonus. Limited Time OpportunityLocation:Milford, MAJob opportunities (more...)

Company: Amazon Workforce Staffing

Location: Woonsocket

Posted on: 09/15/2020

Amazon Workforce Staffing: Seasonal Reduced-Time Amazon Warehouse Worker With Bonus Potential And Be

Description: Seasonal Part-time Warehouse Team Member 1000 sign-on bonusHourly pay rate:Earn 15.25/hr or more, plus benefits and a 1000 bonus Limited Time OpportunityLocation:Milford, MAJob opportunities vary (more...)

Company: Amazon Workforce Staffing

Location: Woonsocket

Posted on: 09/15/2020

Amazon Warehouse Assistant (Full-Time) - Day and Night Shifts Available - Up to$1000 sign on Bonus +

Description: Seasonal Full-time Warehouse Team Member - 1000 sign-on bonus Hourly pay rate: Earn 15.25 - 18.25/hr, plus benefits and a 1,000 sign-on bonus. Limited Time Opportunity Location: Milford, (more...)

Company: 8162

Location: Woonsocket

Posted on: 09/15/2020

Amazon Workforce Staffing: Full-Time Warehouse Team Member - $500 Sign-On Bonus

Description: Full-time

Company: Amazon Workforce Staffing

Location: Woonsocket

Posted on: 09/15/2020

Amazon Workforce Staffing: Seasonal Full-Time Warehouse Team Member - $1000 Sign-On Bonus

Description: Seasonal Full-time Warehouse Team Member 1000 sign-on bonusHourly pay rate:Earn 15.25/hr or more, plus benefits and a 1,000 sign-on bonus. Limited Time OpportunityLocation:Milford, MAJob opportunities (more...)

Company: Amazon Workforce Staffing

Location: Woonsocket

Posted on: 09/15/2020

Amazon Workforce Staffing: Full-Time Amazon Package Sorter With Sign-On Bonus

Description: Seasonal Full-time

Company: Amazon Workforce Staffing

Location: Woonsocket

Posted on: 09/15/2020

Company or Job Title Location (City, State) Powered by Company reviews , salary info, and interview questions for thousands of jobs .

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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Principal Research Associate/Scientist
Description: Middle School Academic Technology Specialist Company: Buckingham Brown Nichols School Location: Cambridge Posted on: September 16, 2020 Job Description: If you are unable to complete this application (more...)
Company: Amazon Workforce Staffing
Location: Woonsocket
Posted on: 09/21/2020

Principal Research Associate/Scientist
Description: Systems Integration and Test Engineer Sr. / RF Microwave / LabVIEW Company: Lockheed Martin Location: Chelmsford Posted on: September 13, 2020 Job Description: Systems Integration and Test Engineer (more...)
Company: The Lockheed Martin Chelmsford
Location: Woonsocket
Posted on: 09/21/2020

Principal Scientist
Description: Senior Manager/Associate Director, Marketing - Rare Disease Company: UCB S.A. Location: Cambridge Posted on: September 16, 2020 Job Description: Keywords: UCB S.A., Cambridge , Senior Manager/Associate (more...)
Company: Amazon Workforce Staffing
Location: Woonsocket
Posted on: 09/21/2020


Part - Time Warehouse Operator - $15.25 - $18.25/hr
Description: Seasonal Full-time Warehouse Team Member - 1000 sign-on bonus Hourly pay rate: Earn 15.25 - 18.25/hr, plus benefits and a 1,000 sign-on bonus. Limited-Time Opportunity Location: Bellingham, (more...)
Company: Amazon Workforce Staffing
Location: Woonsocket
Posted on: 09/21/2020

Principal Research Associate/Scientist
Description: Senior Manager, Oncology Cell Therapy - Global Regulatory Affairs Company: Takeda Pharmaceuticals International GmbH Location: Cambridge Posted on: September 16, 2020 Job Description: The health (more...)
Company: Amazon Workforce Staffing
Location: Woonsocket
Posted on: 09/21/2020

Principal Research Associate/Scientist
Description: Company: Lever Location: Cambridge Posted on: September 16, 2020 Job Description: Why Join Us Be a hero for our rare disease patients Ultragenyxis a commercial-stage biopharmaceutical company (more...)
Company: Amazon Workforce Staffing
Location: Woonsocket
Posted on: 09/21/2020

Marketing Safety Study Lead
Description: Company: Takeda Pharmaceuticals International GmbH Location: Cambridge Posted on: September 12, 2020 Job Description: The health and safety of our employees and candidates is veryimportant to us. (more...)
Company: Takeda Pharmaceuticals International GmbH
Location: Woonsocket
Posted on: 09/21/2020

Principal Electrical Engineer
Description: Company: Raytheon Intelligence amp Space Location: Burlington Posted on: September 12, 2020 Job Description: Are you ready safer world What does it take to make the world a safer place It takes (more...)
Company: Amazon Workforce Staffing
Location: Woonsocket
Posted on: 09/21/2020

Principal Research Associate/Scientist
Description: Company: Reliance Recruiting Location: Cambridge Posted on: September 16, 2020 Job Description: Director Clinical Operations 2020-07-16T10:36:12.315-04:00 Cambridge Director, Clinical Operations (more...)
Company: Amazon Workforce Staffing
Location: Woonsocket
Posted on: 09/21/2020

Principal Scientist
Description: Company: Spectraforce Technologies Inc Location: Cambridge Posted on: September 16, 2020 Job Description: Job Description What we do SPECTRAFORCE is an award winning global staffing, IT servicesand (more...)
Company: Amazon Workforce Staffing
Location: Woonsocket
Posted on: 09/21/2020

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Cambridge RSS job feeds