Job Title: Computer System Validation Engineer
Location : Kalamazoo MI
· Experience in MES Validation
· Very good experience is SDLC and Computer Systems Validation (CSV)
· Agile Methodology experiencepreferred
· Supply chain experiencepreferred. Experienceworking withSAP ECC preferable.
· Experience in creation/maintenance & implementation of SOPs
· Experience in the use of HP Quality Center and similar tools to manage software testing and requirements.
· Worked in cGMP, 21 CFR Part11 and GAMP 5 environment? Hands on authoring/ review/ approval of computer system validation deliverable, inclusive of requirements gathering. Functional specification, test/validation plans, protocols, test scripts / cases, tractability matrix and summaries
· Ensures documentation and practices meet quality standards, applicable regulatory compliance and IS guidelines/policies
· Review functional design specification, technical design specifications for clarity, Good documentation practices.
· Review the accuracy and completeness of software validation deliverables created by process work streams
· Knowledge of software testing. Ability to create Traceability Matrices linking approved requirements to test cases within HPALM.
· Create validation deliverables like Requirements, Data Migration Plan, Summary Reports, work instruction documents for tools
· Ability to pull necessary details from an object level Technical Design Specs and Functional Design specs and consolidate the information in a Master Technical and Functional Design document that is presentable to an external regulatory agency.
· Experience working in an agile environment is preferred
· Keep the Program Validation Lead/Validation Project Manager informed of any issues regarding the quality of deliverables or any potential sources of impact to the project timeline.
· Report on the status of validation deliverables and supportother compliance work as necessary
· High level knowledge working with HPALM
· Experience with MS Office applications.
· Experience working in a cross functional system and within scrum teams.
· Experience in Software validation and compliance activities in Pharma (GMP) environment
· Experience in working with GxP applications
· Domain : LS - Regulatory IT Compliance ( CSV, ERES Compliance)
· SAP Validation, Regulatory and Compliance, Validation, MES