Guardian SystechValidation Lead
Guardian SystechValidation Lead
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1 Vacancy
Job Description
Foster cityCA/Raleigh NC(Remote opportunity
Contract6
Note:: Travel readiness to client location whenever needed
Experience in providing tier2 support in 24/7 pharmaceutical manufacturing and packaging operations
Worked in direct support of and along with the maintenance staff to maintain both complex and straightforward systems used in packaging operations
Experience with Systems Management (disaster recovery problem management incident management change management etc)
Experience in Systech suite of products (Systech Guardian Advisor and Sentri) Track & Trace Serialization & Brand Protection Systech
Experience working with Systech product team and process automation and engineering teams.
Experience and indepth understanding of all system lifecycle deliverables from Commissioning & Qualification (C&Q) and Computer System Validation (CSV) documents through System Retirement. This includes deliverables such as Planning (Project Validation Plan or Validation Master Plan) User/Functional Requirements Design Specifications Design Qualification (DQ) Commissioning (FAT SAT Startup) Qualification Test Protocols (IQ/OQ/PQ) Process Validation (PV).
Experience in pharma packaging processes and packaging equipment custom software
Strong problemsolving and strong analytical skills are essential. Ability to troubleshoot issues and provide timely resolution.
Excellent analytical organizational team and project management and documentation skills
Excellent written verbal communication skills
Strong understanding of software development lifecycle and maintenance plans
Experience working in a support role in a flexible schedule
Employment Type
Full Time
