CSV Validation Engineer Hybrid in Raritan, NJ, US

• Posted 3 hours ago

• Updated 2 hours ago Contract W2 Remote $40 - $45/hr Saim Technologies Fitment Dice Job Match Score™ 🔢 Crunching numbers...

Job Details Skills Acceptance Testing Acquisition Amazon Web Services Biotechnology Communication Computerized System Validation Documentation Inventory GxP JIRA Management Manufacturing Medical Devices Microsoft Azure Pharmaceutics Regulatory Compliance Scripting ServiceNow Specification Gathering Supervision System Testing Test Methods Test Plans Traceability Matrix WIS Writing Acceptance Testing Acquisition Amazon Web Services Biotechnology Communication Computerized System Validation Documentation Inventory GxP JIRA Management Manufacturing Medical Devices Microsoft Azure Pharmaceutics Regulatory Compliance Scripting ServiceNow Specification Gathering Supervision System Testing Test Methods Test Plans Traceability Matrix WIS Writing Summary Job Title:

Validation Lead Location:

Raritan, NJ (Remote and Hybrid preferred)

Mandatory:

Computer System Validation Validation experience,

Infrastructure and Tools AWS/Azure Key Responsibilities:

Candidates need to have hands-on experience in validating and implementing infrastructure systems and tools. e.g. AWS, Azure, JIRA, ServiceNow etc. Any recent experience with divestiture/separation in J&J a huge plus. e.g. Manufacturing site cutovers (infrastructure and applications), Ability to manage multiple dispositions for multiple J&J Managers with limited supervision. Must have proven track record of Large Acquisitions & Separations. Strong CSV Expertise, especially within Acquisition/Divestiture/Separation. Ability to manage end-end from Inventory, assessments, remediations to final dispositions; 7-10 years of relevant experience; has experience of leading/advising Junior and Senior resources. Specifically in the Pharmaceutical, biotechnology, or medical device industry. Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation; Define and implement Risk based validation activities. 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, SOPs/WIs). 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. 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 Employers have access to artificial intelligence language tools ("AI") that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id:

91131463

Position Id:

9080920 Posted 3 hours ago Company Info About Saim Technologies Saim Technologies provides a variety of services related to Information Technology and out sourcing and has been recognized as a one of the emerging leader in software solutions. We provide custom software development, Staffing, Training and engineering services. We offer Enterprise level web based applications, web services, technical resources, Enterprise level database, software hosting, technical support services, routine programming, and more. Our IT services focus on providing you with increased business performance by leveraging our technological expertise, business knowledge, process quality, and people. Our dedicated Centers of Excellence and practices around each of our service offerings enable us to continuously improve processes, retain project learning, and expand knowledge repositories to deliver consistent value.