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Validation Specialist / Technical Writer/ CSV

  • MaxisIT Inc
  • 01/20/19
  • Westborough, MA
  • 01581
  • DOE / Yearly
  • Contractor
We have an excellent job opportunity with one of our client, huge pharmaceutical company headquarter is currently seeking for a Validation Specialist III for a contract position.
Job Title: Validation Specialist III
Location: Westborough, MA.
The objective of this SOW is to provide the minimum requirements expected of candidates to fulfill the role of Validation / Tech Writer for project/activities associated with LWLIMS System, in Information Technology and Solutions (ITS) global Design and Build area.
System Description:
The LWLIMS application is a laboratory information management system (LIMS) serving manufacturing Quality Control labs across major sites within company, Vaccine global business unit. Our company is a global leader in the growing and highly innovative vaccines industry. We develops, produces and commercializes the world's largest range of vaccines and combination vaccines that provide protection against a variety of diseases. The product portfolio includes a range of vaccines for children and an adult and traveler's range. Our company have locations in North America has locations in MA, PA and Toronto CA
The current LWLIMS system provides nearly full range of functionalities covering majorities of testing associated information for vaccine manufacture purpose.It contains key interface that links LWLIMS to company SAP instances. The interface maintains two way communciation for testing initiation and testing confirmation. There are major risks and limitations of the NA interface due to the technology it has been based on, and the need is urgent to upgrade the interface with TIBCO Enterprise Application Integration (EAI)Technology. The NA SAP-LWLIMS interface upgrade project is scheduled to kick off in 2016 with focus on individual site instance specifically. The interface upgrade for all NA sites will be completed so the project is to be be concluded in 2017.
Primary Responsibilities:
The Validation / Tech Writer will need to be dedicated 100% to LWLIMS associated project/activitiesWorking with client ITS Project Leader (IPL) and Validation Expert (VEX) to develop validation deliverables as per agreed validation and test strategy
Validation deliverables: Validation Plan (contribute), Test Strategy/Cases (contribute), Risk Assessment (contribute), Test Scripts (responsible), Anomaly records (responsible), Validation and Test reports (contribute / responsible)
Work with User Project Leader (UPL) and Key User representatives (KUs) to review test scenarios, specify and setup appropriate data sets to be used in test execution
Support users and other ITS team members in test execution including test preparation and anomaly / defect management
Other tasks and duties as assigned
Key Attributes Required of Candidates for this Role:
Must have three to five years prior experience in role of Validation / Tech Writer for Quality Control LIMS project in Biologics, Biopharmaceutical or traditional pharmaceutical environment
Overall proficiency/familiarity with key related features of Labware v5/v6; Work experience on Labware " SAP interface associated project preferred
Understanding of GxP regulations and Computer Validation principles
Understanding of Document Management principles
Demonstrated technical writing and oral communication skills
Must be expert at developing and maintaining validation deliverables
Flexibility to adopt and embrace company's PUMA and other related internal processes and procedures, principles and program methodology
Strong drive to accomplish assigned tasks, a "self starter
Take ownership of assigned tasks and be accountable for their completion as per defined project plan
Strong collaborator across all teams and streams in the completion of assigned tasks and those of other team members
Escalate and identify potential issues to PM/IPL and others on the team in a timely and responsible manner
Proficiency/experience with Client Quality Center (testing tool), Documentum (EDMS) and/or TrackWise (change management tool)
Detail oriented -- ability to get things done "right the first time " in a regulated environment
Ability to work independently, efficiently and with a sense of urgency, within the established framework (thus maximizing output with sufficient quality, while also minimizing the need for unnecessary involvement from teammates or business contacts)

Education :Bachelor's degree or above: Computer Science (preferred) or Business/Sciences with computer science concentration
..If you are qualified, available, interested, planning to make a change, or know of a friend who might have the required qualifications and interest, please call me ASAP at (732) 666-0112, even if we have spoken recently about a different position. If you do respond via e-mail please include a daytime phone number so I can reach you. In considering candidates, time is of the essence, so please respond ASAP.

Note: Please allow me to reiterate that I chose to contact you either because your resume had been posted to one of the internet job sites to which we subscribe, or you had previously submitted your resume to us. I assumed that you are either looking for a new employment opportunity, or you are interested in investigating the current job market.
If you are not currently seeking employment, or if you would prefer I contact you at some later date, please indicate your date of availability so that I may honor your request. In any event, I respectfully recommend you continue to avail yourself to the employment options and job market information we provide with our e-mail notices.

Thanks & Regards

Sona M
MaxisIT Inc
Metuchen, NJ
Phone: (732) 666-0112
Fax: (732) 909-2393

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