- Professional
- Escritório em Winston-Salem
THE ROLE: The Validation Engineer is responsible for planning, executing, and documenting validation activities to ensure that equipment, systems, and processes meet regulatory and quality standards. This role supports the development and implementation of validation protocols (IQ/OQ/PQ), collaborates with cross-functional teams, and ensures compliance with internal procedures and external regulations. The ideal candidate is detail-oriented, technically proficient, and committed to maintaining a high standard of quality and compliance in a regulated environment.
HOW YOU WOULD CONTRIBUTE:
• Responsible for supporting the Validation/Qualification program by:
1. Develop and author validation/qualification protocols at the Herbalife Manufacturing facility for processes, equipment, facilities, and utility systems.
2. Execute validation/qualification protocols for processes, equipment, facilities, and utility systems. at the Herbalife Manufacturing facility.
3. Prepare validation/qualification summary reports for the executed protocols.
• Support change control activities and assess validation impact.
• Identify and resolve deviations and non-conformities, ensuring timely CAPA (corrective action/preventive action) activities, implement continuous improvement opportunities related to validation.
• Assess validation impact of changes, deviations, and CAPAs.
• Participate in Design Qualification (DQ) reviews to ensure user and functional requirements are met.
• Support periodic requalification/revalidation based on lifecycle approach.
• Maintain validation lifecycle documentation and ensure timely revalidation as needed.
• Participate in audits and inspections, providing validation-related documentation and support.
• Ensure compliance with regulatory guidelines and industry standards.
• Contribute to the development and review of required documentation (SOP's, Protocols, Change Requests/Change Controls) to support validation activities.
• Identify gaps in validation processes and implement efficiency improvements.
• Apply Quality by Design (QbD) principles to enhance product and process robustness.
• Applies standard techniques and procedures to carry out a series of scientific and/or engineering tasks.
• Provide adequate reporting and communication of projects to project manager, stakeholders and/or department manager.
• Other duties as assigned.
SKILLS AND BACKGROUND REQUIRED TO BE SUCCESSFUL:
Skills:
• Strong technical writing skills and experience in writing and executing IQ, OQ and PQs, Process Verifications (PVs), and Continuous Verification programs.
• Well-organized and technically sound in understanding validation principles.
• Strong technical writing skills with a thorough understanding of good documentation practices.
• Ability to provide consultation and input to support the manufacturing facility as it relates to the qualification or validation process.
• Ability to prioritize projects and manage assigned resources to meet organizational goals and objectives.
• Ability to track and update schedules to provide upper management visibility of milestones and achievements
• Ability to investigate and resolve OOS results, deviations or non-conformances.
• Technical aptitude and ability to work in fast paced environment with competing priorities.
• Ability to operate with minimal direction and supervision and be able to manage and track status of activities.
• Proficient with Microsoft Office Suite including MS Project and Visio.
• Excellent teamwork, organizational, communication and problem-solving skills.
Experience:
• 3–5 years of related validation experience in a cGMP environment preferably in food/pharmaceutical based GMP manufacturing facility.
• Experience with equipment qualification methodologies
• Strong knowledge and experience in cGMP CA/PA, root cause analysis, risk assessment and investigation tools and techniques.
Education:
• Bachelor’s degree in science/engineering or equivalent technical degree.
