Sr. Validation Engineer II

Responsibilities

• Lead the execution of CD, PQ, CV, PV, and RV activities for equipment, systems, facilities, and utilities.
• Act as a project manager for validation deliverables, ensuring implementation within timelines and financial forecasts.
• Serve as a technical Subject Matter Expert (SME) on cross-functional teams regarding computerized systems and facilities.
• Manage and supervise contractors or consultants as required.
• Participate in change control review boards and own validation-related change control tasks.
• Maintain inspection readiness and act as an SME during Health Authority inspections.
• Generate, execute, and manage detailed project plans for validation maintenance and change management.
• Troubleshoot validation issues and foster interdepartmental partnerships to resolve technical problems.

Requirements

• BS in Engineering.
• Minimum of 10+ years of experience in validation within a regulated environment.
• Advanced knowledge of commissioning and qualification for equipment, computerized systems, and utilities.
• Strong knowledge of cGMP and applicable regulatory guidelines.
• Proficiency in technical and business writing.
• Ability to perform statistical analysis of validation test results.
• Experience working in controlled or clean room environments.

Preferred Qualifications

• Experience with systems such as LIMS, MES, ERP, SCADA, or DCS (e.g., Delta V).
• Proven ability to manage complex validation projects and timelines independently.

Benefits

• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off and company holidays.
• Well-being benefits.

About the Company

Takeda is an industry-leading, global pharmaceutical company dedicated to putting patients at the center of everything they do. Driven by the values of Integrity, Fairness, Honesty, and Perseverance, Takeda strives to deliver better health and a brighter future through leading innovation in medicine.