Find & Apply For Validation Engineer Jobs in Franklin Township, New Jersey

Job Description Senior Technical Lead Somerset, New Jersey Job Summary Previous JNJ experience required, Onshore US, or Nearshore

•3-7 years of relevant experience; can work independently and guide/mentor Junior resources. Experience in the Pharmaceutical, biotechnology, or medical device industry with System Development Lifecyle in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. Knowledge of FDA guidance's and industry standards (i.e., GAMP) Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs. Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures. Ability to Review Automated Test script Strong verbal and written communication skills. Ability to work as a team player, lead a team or accomplish tasks without supervision. Ability to work with remote teams and support several changes/projects simultaneously. Ability to provide Validation guidance, timely reviews, and escalations to TQ management. Hands on experience with validation of Data Solutions (Data Lakes, Data Warehouses) and familiar with Snowflake, Databricks is preferred. Key Responsibilities Previous JNJ experience required, Onshore US, or Nearshore

•3-7 years of relevant experience; can work independently and guide/mentor Junior resources. Experience in the Pharmaceutical, biotechnology, or medical device industry with System Development Lifecyle in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. Knowledge of FDA guidance's and industry standards (i.e., GAMP) Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs. Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures. Ability to Review Automated Test script Strong verbal and written communication skills. Ability to work as a team player, lead a team or accomplish tasks without supervision. Ability to work with remote teams and support several changes/projects simultaneously. Ability to provide Validation guidance, timely reviews, and escalations to TQ management. Hands on experience with validation of Data Solutions (Data Lakes, Data Warehouses) and familiar with Snowflake, Databricks is preferred. Skill Requirements Other Requirements Maximum Salary (US): Minimum Salary (US): Apply now Job Alerts Link