Validation Lead

Validation Lead

Location: Raritan, NJ (Remote)

Duration: 6+ Months

Job Description:

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.

Key Responsibilities

• Candidates need to have hands-on experience in validating GxP GEN AI based solutions and IMPACT system
• Ability to manage multiple dispositions for multiple J&J Managers with limited supervision.
• 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.