Validation Lead

Job Description

Job Description

Job Overview:

• 7-10 years of relevant experience in Infrastructure Qualifications and Business Systems Validations.
• Experience leading or advising junior and senior resources.
• Specific experience in the pharmaceutical, biotechnology, or medical device industry.
• Experience in FDA and/or global regulated environments with a good understanding of GxP standards and risk-based validation.
• Strong Computer System Validation (CSV) expertise, especially within acquisition, divestiture, and separation contexts.
• Experience in writing and executing documentation for all aspects of validation deliverables including requirements, compliance/validation plans, test protocols, test summary reports, and SOPs/WIs.
• Experience in reviewing system test and user acceptance test scripts, traceability matrices, and design specifications.
• Experience in QA methodologies, including designing, reviewing, and approving test plans and procedures.
• Strong verbal and written communication skills.

Responsibilities:

• Independently support business separation activities for large global and regional GxP computerized systems with minimal supervision.
• Manage end-to-end processes from inventory and assessments to remediations and final dispositions.
• Define and implement risk-based validation activities.
• Review and approve test plans, systems, and UAT test scripts.

Nice to Have:

• Recent experience with acquisitions, separations, or divestitures within a similar organizational environment.

Skills:

• Computer System Validation.
• M&A Data Migration.
• Infrastructure Qualification.
• Data Platform Domain.
• GxP Standards.
• Risk Based Validation.
• QA Methodologies.
• UAT Testing.

Qualification And Education:

• 7-10 years of relevant experience in Infrastructure Qualifications and Business Systems Validations.

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.