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Lead Engineer for Manufacturing Standards
3 months ago
Position Overview
As a Senior Engineer in Manufacturing Compliance at CHEP, you will spearhead initiatives to establish and uphold manufacturing standards, validation protocols, and documentation practices across our international engineering and automation teams. Utilizing your knowledge in engineering standards, validation techniques, and documentation oversight, you will ensure adherence to regulatory mandates, industry benchmarks, and internal change management systems.
Key Responsibilities
- Direct the formulation and execution of manufacturing standards, procedures, and guidelines to guarantee uniformity, quality, and compliance for all forthcoming global manufacturing equipment.
- Develop validation protocols and methodologies for manufacturing machinery, processes, and systems, including IQ/OQ/PQ frameworks, risk evaluations, and validation documentation.
- Create and sustain comprehensive documentation systems and procedures for manufacturing processes, machinery, and systems, ensuring precise record-keeping and traceability.
- Ensure adherence to regulatory mandates, industry benchmarks, and internal quality management systems.
- Continuously assess and revise operational specifications throughout the project lifecycle, integrating feedback, lessons learned, and alterations in project requirements to maintain relevance and effectiveness.
- Work collaboratively with cross-functional teams to develop Statements of Work (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 protocols, 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.
- Promote continuous improvement initiatives to enhance manufacturing standards, validation protocols, and documentation practices, leveraging data-driven insights and best practices.
- Engage in audits and reviews to verify compliance with internal processes and external standards.
- Provide training and support to manufacturing teams on manufacturing standards, validation protocols, and documentation requirements, ensuring understanding and compliance.
Qualifications
- Demonstrated experience in manufacturing engineering, quality assurance, validation, or documentation management roles within a global manufacturing context.
- In-depth knowledge of engineering standards, validation methodologies, and documentation management practices, with a focus on manufacturing processes and systems.
- Exceptional project management capabilities and the ability to lead cross-functional teams in the development and implementation of manufacturing standards, validation protocols, and documentation practices.
- Proven experience in establishing and managing a robust change control process to document best practices, capture lessons learned, and facilitate continuous improvement initiatives across global manufacturing operations.
- Experience in a global or multinational environment, with exposure to diverse cultures and business practices.
Skills and Expertise
- Operations experience, supporting production in continuous improvement opportunities.
- Strong communication and interpersonal skills, with the ability to collaborate effectively with global teams and stakeholders at all levels of the organization.
- Possess a comprehensive understanding 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.
