Senior Contract Manufacturing Process Engineer

Senior Manufacturing Engineer Job

We are seeking a highly skilled Senior Manufacturing Engineer with extensive experience in managing and optimizing contract manufacturing processes. The ideal candidate will have expertise in overseeing the entire contract manufacturing process, ensuring that products meet quality standards and are delivered efficiently.

1. Contract Manufacturing Management:
   1. Develop and maintain strong relationships with contract manufacturing partners to ensure alignment with company requirements and standards.
   2. Oversee and manage the entire contract manufacturing process, execution, and continuous improvement initiatives.
   3. Coordinate with contract manufacturers to address and resolve production issues and implement corrective actions as needed.
   4. Research, justify, and propose capital equipment and/or processes investments.
   5. Liaise with the Sourcing group to identify new suppliers as needed and to identify and capitalize on opportunities for the reduction of cost, yield, or quality improvements with existing or new vendors via process improvement or transfer.
   6. Coordinate with Purchasing and Quality Engineering to improve the Quality Systems procedures relating to suppliers.
2. Process Optimization:
   1. Collaborate with internal teams to review and optimize manufacturing processes and product designs to enhance efficiency and reduce costs.
   2. Analyze production data and metrics to identify areas for improvement and implement solutions to optimize manufacturing operations.
   3. Perform process capability assessments and develop strategies to improve yield and reduce defects.
   4. Provide input and guidance to new product Introduction teams on best practices for MFG production, test, and packaging processes and procedures.
3. Quality Assurance:
   1. Develop and implement quality control procedures to ensure products meet design specifications and industry standards.
   2. Liaise with Supplier Quality Engineering and Sustaining Engineering (CAPA) to ensure the effective completion of Supplier Corrective Actions. Support the assessment of non-conforming products received from suppliers.
   3. Provide technical support and input when required to the Suppler Audit process and liaise with Suppliers and Regulatory Assurance to obtain supplier-related information required for regulatory submissions.
4. Project Management:
   1. Lead manufacturing projects from initiation through to completion and resource allocation.
   2. Prepare and present project reports, including progress updates, performance metrics, and recommendations for improvements.
   3. Ensure projects are executed on time, within scope, and within budget constraints.
5. Technical Support:
   1. Provide technical guidance and support to contract manufacturers regarding manufacturing processes, equipment, and materials.
   2. Troubleshoot and resolve technical issues related to production processes, equipment performance, and product quality.
   3. Give technical guidance to Associate Engineers, technicians, and production employees.
6. Compliance and Documentation:
   1. Ensure that all manufacturing activities comply with industry regulations, company policies, and safety standards.
   2. Maintain comprehensive documentation related to manufacturing processes, quality control measures, and project activities.
   3. Develops and executes validation protocols (e.g. IQ, SV, TMV, MVP, MVR) in compliance with regulatory requirements.
   4. Develops manufacturing procedures to support transferred manufacturing processes.
   5. Reviews and approves documents prepared by sister sites or contractor (e.g. Tool Validation report, Risk Assessments, Change Notes).