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Computer Systems Engineer

4 months ago

Waltham, United States GForce Life Sciences Full time

Responsibilities

• Perform validation activities supporting requirements gathering, validation planning, design qualification, authoring test plans and test scripts, execution of test scripts, discrepancy management, and authoring system description and validation summary reports.

• Perform system-based risk assessments in determining GxP applicability of the system, associated risk and resulting validation activities per risk.

• Support the Validation Team on all aspects of the computer system/computerized equipment lifecycle during projects and operational phase, including but not limited to the development, review and execution of validation documentation.

• Provide validation support during the operational phase by performing change impact assessments, determine the required level of testing, authoring and executing test scripts related to the change and change qualification report.

• Support periodic review of computer systems.

• Support periodic user access review of computer systems/computerized equipment.

• Support business administration of the electronic system (ValGenesis) used for validation lifecycle management.

• Support training of end users on the electronic system (ValGenesis) used for validation lifecycle management.

• Support management of Validation Templates in ValGenesis in terms of authoring/updating templates.


Qualifications

  • Bachelor’s degree in a Science or Engineering discipline with 5 years of relevant experience in computer system validation.


Specialist/ Technical Qualifications / Knowledge

• Experience computer systems supporting R&D functions like Clinical, Pharmacovigilance/Drug Safety, Medical Affairs, Supply Chain, Regulatory Affairs and Quality Assurance is a plus

• Experience with ValGenesis is a plus

• Practical experience with quality risk management and risk-based validation approaches.

• Knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9 and Q10. Understanding of industry standards and best practices for computer system validation such as GAMP 5 and ASTM E2500