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Senior Manufacturing Engineer
2 months ago
As a Senior Manufacturing Engineer for Standards Validation Documentation at CHEP, you will lead efforts to establish and maintain manufacturing standards, validation processes, and documentation practices across our global engineering and future automation teams. Leveraging your expertise in engineering standards, validation methodologies, and documentation management, you will ensure compliance with regulatory requirements, industry standards, and internal change control management systems.
In this role you will be responsible for working with the global engineering teams and suppliers to ensure that all future automation equipment adheres to local/regional requirements as well as meets or exceeds all CHEP equipment quality standards and specifications. This role will be responsible to lead detailed technical reviews regarding requirements and execution strategies for all future equipment in development.
Major/Key Accountabilities
- Lead the development and implementation of manufacturing standards, procedures, and guidelines to ensure consistency, quality, and compliance for all future global manufacturing equipment.
- Establish validation processes and methodologies for manufacturing equipment, processes, and systems, including IQ/OQ/PQ protocols, risk assessments, and validation reports.
- Develop and maintain comprehensive documentation systems and procedures for manufacturing processes, equipment, and systems, ensuring accurate record-keeping and traceability.
- Ensure compliance with regulatory requirements, industry standards, and internal quality management systems.
- Continuously review and update operational specifications throughout the project lifecycle, incorporating feedback, lessons learned, and changes in project requirements to maintain relevance and effectiveness.
- Collaborate closely with cross-functional teams to develop SOWs that accurately reflect project requirements, milestones, and acceptance criteria, facilitating effective project planning and execution.
- Collaborate with global teams to ensure alignment and consistency in manufacturing standards, validation processes, and documentation practices across all manufacturing sites.
- Establish Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) to validate system performance against defined specifications and standards.
- Drive continuous improvement initiatives to enhance manufacturing standards, validation processes, and documentation practices, leveraging data-driven insights and best practices.
- Participate in audits and reviews to verify compliance with internal processes and external standards.
- Provide training and support to manufacturing teams on manufacturing standards, validation processes, and documentation requirements, ensuring understanding and compliance
Experience
- Proven experience in manufacturing engineering, quality assurance, validation, or documentation management roles in a global manufacturing environment.
- Strong knowledge of engineering standards, validation methodologies, and documentation management practices, with a focus on manufacturing processes and systems.
- Excellent project management skills and the ability to lead cross-functional teams in the development and implementation of manufacturing standards, validation processes, and documentation practices.
- Proven experience in creating and managing a robust change control process to document best practices, capture lessons learned, and facilitate continuous improvement initiatives across global manufacturing operations.
- Experience working in a global or multinational environment, with exposure to diverse cultures and business practices.
Skills and Knowledge
- Operations experience, supporting production in continuous improvement opportunity.
- Strong communication and interpersonal skills, with the ability to collaborate effectively with global teams and stakeholders at all levels of the organization.
- Possess an in-depth comprehension of the Factory Acceptance Test (FAT), Site Acceptance Test (SAT), and Commissioning, Qualification, and Validation (CQV) processes within the context of development projects.
- Certification in quality engineering, validation, or documentation management from recognized industry organizations.
- Knowledge of Lean Six Sigma or other continuous improvement methodologies for manufacturing process optimization.
- Experience with auditing manufacturing processes and documentation systems for compliance and quality assurance purposes.
- Familiar with project management methods and tools such as MS Project.