Vertex Pharmaceuticals Incorporated.
10045BR,ActualValueFromSolar:null},Department Scientific Computing ,ActualValueFromSolar:null},Posting location Boston, MA ,ActualValueFromSolar:null},Job Title/Position Title Lead Analyst, GIS,ActualValueFromSolar:null},Posting Job Title Senior Analyst,ActualValueFromSolar:null},Job Description
Vertex Pharmaceuticals, Inc. is seeking a Senior Analyst specializing in Computer Systems Validation to join the Lab Systems team within the IT department in Boston, MA. The Lab Systems team is responsible for implementing and supporting a broad array of computer systems supporting laboratory needs, from instrument workstations to scientific data management. This key team member will provide validation and testing oversight for any projects that involve deploying, updating, or retiring validated computer systems. Partnering with project managers, business analysts, technical leads, scientists, and quality assurance, the person in this role is responsible for ensuring that each project has an appropriate validation strategy in place, that validation testing is conducted in accordance with the applicable policies and procedures, and that all requirements are met before releasing the system or service for use. Additionally, this team member will serve as a liaison to the Quality organization, providing oversight and tracking of procedure reviews and periodic reviews of system validations, coordinating document archiving, supporting audits, and coordinating training requirements for the team.
The responsibilities of this position include, but are not limited to, the following:
* Work on multiple project teams simultaneously, providing validation expertise and oversight
* Develop and approve testing and validation strategies for computer systems projects
* Develop and review validation deliverables, including plans, requirements, and summary reports
* Develop and review verification scripts
* Review vendor-provided test materials (IQ/OQ/PQ; Automated Validation Suites) and services to determine appropriateness for use at Vertex
* Coordinate document approvals in the document management system
* Oversee system testing, test script execution (internal or vendor-provided), test error documentation and resolution, and test script documentation and archiving
* Closely review executed test scripts for GDP errors and omissions
* Manage training requirements and assign training for the Lab Systems team
* Oversee process/procedure updates and ensure the updates are submitted in advance of deadlines
* Oversee periodic system reviews and ensure that resulting observations are identified and addressed
* BA/BS or higher
* 5-7 years of experience working with GxP and 21 CFR Part 11 validated computer systems
Strong written and verbal communication skills
Able to work effectively on teams and drive teams to decisions
Experience with creating test scripts (or other technical writing)
Experience with and/or expertise in:
* Document management software (QUMAS, Documentum, etc.)
* IT change management software (ServiceNow, etc.)
* CAPA management software (Trackwise, etc.)
* Learning Management software (ComplianceWire, etc.)
ITIL concepts and frameworks, including request management, change management, and release management
Lab systems software, such as: electronic lab notebook (IDBS E-Workbook, etc.), chromatography, (Empower, etc.), scientific data management (NuGenesis SDMS, etc.), and/or LIMS.
,ActualValueFromSolar:null},Full-Time or Part-Time Full-Time ,ActualValueFromSolar:null},Company Information
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases.
Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and offices around the world. For several consecutive years, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the Company, please visit ************.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ******************************.
Vertex Pharmaceuticals Incorporated.
Website : http://www.vrtx.com
Vertex is a global biotechnology company that aims to discover, develop and commercialize innovative new medicines so people with serious diseases can lead better lives. Founded in 1989, Vertex today employs more than 2,000 people at sites around the world. In addition to our headquarters in Massachusetts, Vertex has research and development sites and other offices in San Diego, CA; Abingdon, Oxfordshire, UK; Laval, Quebec; Coralville, IA; and Geneva, Switzerland.