CSV Specialist
CSV Specialist
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Job Description
For Computer and System Validation support services in the Business Insights and Technology Department
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelors degree in Engineering Computer Systems or related disciplines combined withat least five (5) years of CSV and Change Control Management within a Pharmaceutical / Biotechnology Environment.
- Experience in:
- Change Control Management
- Reading and interpreting drawings and design specifications or any other technical document.
- Computers and software packages
- GMP local/federal regulatory requirements and documentation procedures pertaining to the pharmaceutical manufacturing plant.
The Personality Part:
- Besides being an CSV Pro youre able to analyze data so that not a single inconsistency gets past you (which allows you to be an amazing problem-solver). Youre also a skilled multitasker with an incredible ability to set priorities. Add to this a commitment to serving customers with high-quality research and products to embracing a diverse work culture and even to the environment and you might just be what were looking for!
AS A PIECE OF FITS YOU WILL: (The day-to-day on the job)
- Developing and managingChange Control recordsfrom initiation through closure including system release for use impact assessment and endorsement.
- PerformingComputerized System Validation (CSV) activitiesin accordance with established standard procedures.
- Communicating task progress roadblocks and unmet requirements to leadership.
- Collaborating with cross-functional teams to review and update project-related documentation.
- Developingtesting protocolsin Application Lifecycle Management (ALM) and other necessary documentation.
- Coordinating meetings with technical and multidisciplinary teams for document development and revision.
- Developing approving and/or executing the following CSV deliverables:CSV Risk AssessmentsSite Risk AssessmentsValidation PlansData Integrity/Data Mapping AssessmentsFactory Acceptance Tests (FAT) and Site Acceptance Tests (SAT)System User Requirements SpecificationsSystem Specifications (Design and/or Functional Specifications)Configuration SpecificationsDesign Review EvaluationsData Migration (if applicable)Initial and Final Traceability MatricesInstallation Qualification (IQ) and Operational Qualification (OQ) protocol tests and reportsValidation Plan Summary Reports andAdministration and Security Standard Operating Procedures (SOPs).
- RevisingBackup and Disaster Recovery SOPsas needed.
- UpdatingInventory Lists.
- Submitting and supportingCybersecurity Assessments.
- Managing document control activities including downloading uploading developing updating reviewing and approving documents within document management systems.
- Completing and documenting required training submitting forms addressing comments and scheduling/conducting follow-up meetings to ensure timely completion of tasks.
We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our companys puzzle: you! We integrate Engineering Construction Maintenance Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible family-oriented and focused on our resources well-being while providing our Pharmaceutical Medical Device and Manufacturing industryclients with top-notch quality talent.Were FITS!
Are you the next piece
Required Experience:
Senior IC
Employment Type
Contract
