We are looking for Validation Lead - Remote / Telecommute for our client in Raritan, NJ
Job Title: Validation Lead - Remote / Telecommute
Job Location: Raritan, NJ
Job Type: Contract
Job Overview:
Pay Range: $45.00hr - $50.00hr
Requirement/Must Have:
- Proven track record of Large Acquisitions & Separations.
- Strong CSV Expertise, especially within Acquisition/Divestiture/Separation.
- 7-10 years of relevant experience.
- Experience leading or advising Junior and Senior resources.
- Experience 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.
- Experience in writing and executing documentation for all aspects of the validation deliverables including Requirements, Compliance/validation Plans, test protocols, Test Summary reports, Compliance/Validation Reports, and 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.
Responsibilities:
- Validate and implement infrastructure systems and tools such as AWS, Azure, JIRA, and ServiceNow.
- Manage end-to-end processes from Inventory, assessments, and remediations to final dispositions.
- Define and implement Risk based validation activities.
- Provide Validation guidance, timely reviews, and escalations to management.
Skills:
- Computer System Validation.
- Infrastructure and Tools.
- AWS.
- Azure.
- JIRA.
- ServiceNow.
- GxP standards.
- Risk based validation.
- QA Methodologies.
Qualification And Education:
- 7-10 years of relevant experience in validation.
- Experience in Pharmaceutical, biotechnology, or medical device industries.
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Benefits
Our Benefits Include:
- Medical, Dental, and Vision Insurance
- 401(k) Retirement Plan
- Health Savings Account (HSA)
- Disability Insurance (Short-Term and Long-Term)
- Life and AD&D Insurance
- Paid Sick Leave (where required by applicable state or local law)
- Supplemental Insurance Plans
- Identity Theft Protection
- Pet Insurance
- Employee Wellness Programs
- Employee Assistance Program (EAP)
- Career Growth and Professional Development Opportunities
Disclaimer: Benefits eligibility, accrual rates, and usage limits may vary based on employment status, length of service, and work location. Paid Sick Leave is provided in strict accordance with applicable state and municipal mandates. Cynet Systems Inc. reserves the right to modify, amend, or terminate any benefit plans at any time in accordance with applicable laws.
About Cynet Systems
Founded in 2010 and headquartered in the Washington, DC metro area, Cynet Systems Inc. is a leading technology staffing and workforce solutions company serving Fortune 500 companies, government agencies, and enterprise organizations across the United States and Canada. We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and professional staffing, powered by a high-performing recruitment engine operating across North America and Asia.
As a nationally and locally certified Minority Business Enterprise (MBE), Cynet Systems is committed to helping organizations build high-performing teams while empowering professionals to grow rewarding careers. Our organization is certified to ISO 9001, ISO 14001, ISO 27001, and SOC 2 Type II standards, reflecting our commitment to quality, security, operational excellence, and customer success.