Validation Lead

Job Title

Job Overview:
Pay Range: $50.00hr - $55.00hr

Requirement/Must Have:

• 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.