What are the responsibilities and job description for the Senior Validation Engineer position at LS Solutions?
Job Title: IT CSV Lead
Location: Remote (Cambridge, MA)
Duration: 12 months contract
JOB DESCRIPTION:
IT CSV Lead
JOB DESCRIPTION Our client is a small Therapeutics organization seeking a Computer Systems Validation Lead to support the overall IT Compliance and CSV processes.
On a day-to-day basis your key responsibilities will be, and not limited to:
· Lead and execute the validation activities for other IT Projects like and not limited to Veeva, SAS, VLMS (Validation Lifecycle Management Software), R Studio
· Responsible for tracking monitoring and controlling validation processes to ensure timely delivery to meet prescheduled to releases
· Provide technical expertise, interpretation, and direction in regard to computer, validation, federal regulations and other quality requirements
· Work with business owners to ensure requirements specifications are defined in a clear testable format
· Effectively work with cross functional teams (business owners, technical team, project manager) to ensure the validated state of the system is maintained
· Ensure requirements are adequate adequately tested following a risk-based approach.
· Insure clear trace ability against all testing performed
· Create updates CSV deliverables, including IQ/OQ, VP, VSR, Trace matrices
· Independent pre-and post-execution review of validation test scripts
· Execute other projects and duties as assigned to ensure compliance across FIFA systems and internal business systems
This candidate must have experience working in the pharmaceutical industry. Additionally, they must have experience working with Veeva and 7 years of CSV experience
Required Skillsets
· Biopharmaceutical
· Veeva Quality Docs, SAS
· Computer Systems Validation (CSV)
· Computer Software Assurance (CSA)
· Strong oral and written English communication skills
Thanks,
Raja
