Senior Validation Engineer

Takeda-posted about 2 months ago
Full-time • Mid Level
Onsite • Thousand Oaks, CA
5,001-10,000 employees
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As Senior Validation Engineer, you will support the operations through the initial qualification to validation maintenance of equipment, systems, facilities, and utilities. Responsible and accountable for performing activities such as Cycle Development (CD), Design Qualification, Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV), and Validation Maintenance. Focused on right first-time execution and continuous improvement. You will report to Head of Engineering Services. This is an on-site position, and you will be required to work all five days from the office.

  • 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 its 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 its 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.
  • Approval of 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.
  • Owner of change control task 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.
  • 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 engineers.
  • Advanced knowledge of equipment, systems, facilities, and utilities in a regulated environment is required.
  • 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.
  • A strong technical and/or engineering knowledge, as well as strong ability to work collaboratively with interfaces to 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.
  • Basic understanding of data and statistical analysis of validation test results.
  • Knowledge of cGMPs or equivalent regulations, validation associated regulations, guidelines, and best practices.
  • Proficient in Microsoft Word and Excel, computer software.
  • U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
  • U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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