Senior Validation Engineer

Role Summary

The Senior Validation Engineer supports operations through the initial qualification to validation maintenance of equipment, systems, facilities, and utilities. They are responsible for activities including Cycle Development (CD), Design Qualification, Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV), and Validation Maintenance, with a focus on right first-time execution and continuous improvement. This is an on-site role; you will work five days a week from the office and report to the Head of Engineering Services.

Responsibilities

• Be a Validation Engineering representative and technical subject matter expert (SME) on cross-functional and multi-site teams related to equipment, systems, utilities, facility, and computerized systems as applicable to the assigned role.
• Create validation documentation including SOPs, risk assessments, traceability matrices, and validation master plans.
• Develop validation protocols (IQ/OQ/PQ) for computer systems as applicable to the assigned role.
• Apply advanced theory, technical principles, and expert judgment to address a broad range of problems.
• Troubleshoot and direct the resolution of Validation issues by fostering effective interdepartmental and cross-functional partnerships.
• Maintain a state of inspection readiness and act as SME in Health Authority inspections.
• Approve commissioning documents, including but not limited to commissioning protocols and reports.
• Evaluate and leverage testing to qualification activities.
• Generate, execute, and manage the detailed project plans and timelines for the execution of CD/DQ/IQ/OQ/PQ/CV/Validation Maintenance, change management activities and their associated documentation.
• Support departmental and capital project validation activities.
• Provide key performance indicators data in a predetermined frequency.
• Own change control tasks of validation activities.
• Execute validation activities aimed at improving Right First-Time.
• Present and provide rationale for the completed work during periodic audits and Health Authority inspections.
• Coordinate and perform tactical activities, including sample collection, coordinating with cross-functional support teams, retrieving data and results, completing documentation, as required per protocols.
• Coordinate and perform equipment and system re-qualification according to procedures and predetermined timelines.
• Foster an environment that encourages continuous learning. Maintain expertise as necessary to stay abreast of technical and industry advancements.
• Support EHS programs and own CAPA records as needed.
• Accountable for behaviors as described in Takeda Standards, policies, and procedures.

Qualifications

• BS engineering with 8+ years' experience in validation.
• Experience with systems like LIMS, MES, ERP, SCADA, or DCS (e.g., Delta V) for computer systems validation.
• Advanced knowledge of equipment, systems, facilities, and utilities in a regulated environment; advanced knowledge of commissioning and qualification of equipment, systems, computerized systems, facility, and utilities is required.
• Familiarity with software development lifecycle (SDLC) and validation tools.
• Knowledge of GAMP 5, FDA 21 CFR Part 11, and other regulatory frameworks.
• Strong technical and/or engineering knowledge with ability to collaborate across Process Engineering, Quality, Project Managers, Facilities, Automation, and other groups.
• Technical expertise to define validation approaches and execution of system validation activities in accordance with cGMP and applicable regulations, procedures, and industry guidance.
• Advanced understanding of data and statistical analysis of validation test results (and basic understanding where appropriate).
• Knowledge of cGMPs or equivalent regulations, validation-related regulations, guidelines, and best practices.
• Proficient in Microsoft Word and Excel.

Education

• BS Engineering

Additional Requirements

• On-site position requiring five days in the office.
• Work in controlled environments with gowning and protective clothing; may require respiratory protection in certain areas.
• Cold, wet environment exposure; possible shift work, including weekends, or supplemental hours as necessary.
• May require work around chemicals and other hazardous substances.
• Physical exertion is light; ability to work in clean room environments requiring gowning.
• May be assigned to different shifts or alternative hours as needed; availability outside regular business hours may be required.