Responsibilities:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• Lead validation efforts for new GxP systems implementation with limited guidance/supervision: Senior IS Validation Specialist is responsible of the development of validation plans, test plans, design documents, test scripts, validation summary report and traceability matrix for projects where he is assigned.
• Work with project implementation team to ensure compliance of systems and associated documentation with appropriate corporate guidelines and procedures.
• Solve complex validation problems exercising judgment based on the analysis of multiple sources of information.
• Challenge project implementation team in the definition of the testing strategy. Review all validation and non-validation testing confirming that the test steps tie to the requirements, testing support links to the appropriate test script, and any test deficiencies are documented and tracked to closure.
• Review changes submitted for both GxP and non-GxP systems. Lead discussions with change owner until change implementation and ensure changes for GxP and non-GxP systems comply with our current controls and procedures and include the appropriate supporting documentation.
• Lead working sessions with IS stakeholders and Quality to streamline our processes and document/update our Global Standard Operating Procedures.
• Contributes to IS and IS Compliance process improvements by the inputs provided.
• May help train & coordinate the work of junior members of the team and/or of contractors involved in our computer validation activities
• Explain information and train internal and external audiences who are not always familiar with the subject matter requiring persuasion skills

• Background with system development and validation documentation
• 6+ years of Information System experience
• Strong understanding of the principles of Computer systems validation, SDLC methodologies and testing best practices.
• Knowledge of GxP, GAMP5, 21CFR Part11, Eudralex Annex 11 and industry best practices.
• Experience developing, executing and reviewing validation protocols and deliverables.
• Software change management experience in the pharmaceutical and/or medical device industries.
• Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems.
• Strong communication and interpersonal skills and the ability to interact with the business, peers and vendors in a professional manner.
• Ability to work independently with minimal supervision.
• Knowledge of one (or more) following software is nice to have: Valgenesis, ServiceNow and OneTrust

• This role is hybrid between HQ (Pinceton, NJ) and remote