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1+ months

COMPUTER VALIDATION SPECIALIST

Kelly Services
Devens, MA 01434
**BH: 3489648**



***** MUST BE ABLE TO WORK ON AN EMPLOYEE BASIS ***** **NO C2C** ***** REMOTE / on-site blend *****



**Our Client is expanding and currently seeks a**



**COMPUTER VALIDATION SPECIALIST**


**For a 8+month assignment with possible extensions!!**


**LOCATION:** **Devens, Massachusetts**



**_Position is currently remote, but must report to this office after COVID restrictions are lifted._**



**Leverage your GxP - GAMP 5 &** **TECHNICAL skills**



**to help take your career with our Client to**



**the "Next Level" for 2021 and beyond!**



Our Client is seeking a Analytical Instrument Computer System Validation (CSV) Technical Lead to support the Network QC Equipment Lifecycle Senior Manager.



**Responsibilities:**



Develop CSV testing strategies for qualification of the upgraded QC instruments software and associated interfaces (e.g. Nugensis and File Transfer to LES).

Manage the day to day activities associated with upgrading of instruments to operate with Windows10 software, developing plans and schedules for the NQC team to execute in order to meet project deliverables.

Collaborating with IT business partners to develop software configurations in order to meet regulatory and Data Integrity requirements.

Collaborating with IT define data migration solutions and testing plans for system upgrades to Windows 10 compatible software.

Collaborate/liaise with cross functional teams, such as QA, IT, and site QC instrument groups to ensure validation activities completed on schedule to ensure timely release for use in QC.

Provide Technical SME Review and Approval of qualification documents, ensuring compliance with corporate policies, directives and current regulatory requirements for laboratory instruments, including Data Integrity requirements.

Technical Approval qualification related deviations, ensuring root cause identified and ensuring robust CAPAs Plans defined.

Report on qualification status, project timelines, and escalate challenges as appropriate to Network QC Management

Support the Network leadership team in developing & implementing a strategy to standardize QC instruments (make/model/software) and data reporting in order to reduce Data Integrity (DI) risks.






**Requirements:**



Must be capable of independent workload management across multiple project teams.

Minimum of 7 years experience in the pharmaceutical industry with minimum of 5 years experience within Computer System Validation (CSV). Experience with Analytical Instrument software validation is desirable.

Expert Knowledge of regulatory requirements (e.g. 21CFR part 11, EU annex 11) data integrity (e.g. GAMP5, MHRA, FDA, WHO, PIC/S)

Knowledge of GxP industry standards and regulatory guidance related to analytical instrument qualification and data integrity (e.g. USP 1058, GAMP5, MHRA, FDA, WHO, PIC/S)

Demonstrated experience (>2 years) in leading CSV activities, with proven track record of on-time delivery.

Experience with data migration concepts is a distinct advantage.

Must be able to manage schedules and organize meetings across multiple teams/sites. Working knowledge of MS Project, MS teams, Microsoft Word, Power Point and Excel are essential.

Strong interpersonal, oral and written communication skills are essential, including the ability to communicate at all levels with clarity and precision.

Ability to work on multiple complex team projects where independent action and a high degree of initiative are required in resolving problems and developing recommendations.

Ability to work across timelines with advanced notice.

Demonstrated use of critical thinking skills and growth mind-set is an advantage.






**Education:**



MUST have a 4 year degree.













**Important information:**



+ **There is no per diem with this position**

+ **There is no relocation budgeted for this position. If this position requires you to relocate you will be responsible for those costs.**

+ **MUST be able to work without sponsorship or VISA transfer for this position.**



EMAIL: petf054@kellyservices.com






**Why Kelly** **** **?**






By partnering with Kelly Technology, youll have direct connections to top companies around the globegiving you the chance to put your tech skills to work on some of todays most intriguing, innovative, and high-visibility projects. In a world where change is the only constant, our unparalleled connections and IT market expertise help you take your skills exactly where you want to go. Were here to help you gain experience, keep learning, and move your career forward.






**About Kelly** ****






At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.



Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2021-05-14 Expires: 2021-07-15

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COMPUTER VALIDATION SPECIALIST

Kelly Services
Devens, MA 01434

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