What are the responsibilities and job description for the Senior Engineering Leadership Position position at DSJ Global?
About This Exciting Opportunity
We are seeking an experienced Associate Director to join our team at DSJ Global. As a key member of our leadership team, you will be responsible for leading a team of engineers to ensure equipment readiness, troubleshoot issues, maintain compliance, and drive continuous improvement in our FDA-regulated manufacturing facility.
Key Responsibilities:
- Oversee day-to-day equipment performance, qualification status, and change controls.
- Manage utility systems, process/building automation, HVAC, and process equipment.
- Develop and implement operational strategies to optimize procedures for existing processes and new product introductions.
- Coordinate with cross-functional teams including Project Engineering, Validation, Maintenance, Manufacturing, Process Development, and Quality Assurance.
- Represent the function to clients, auditors, and inspectors.
- Direct and approve engineering documentation and reports.
Requirements:
- Bachelor's degree in engineering and 5 years in FDA-regulated manufacturing.
- Strong knowledge of cGMP, engineering practices, equipment design, and regulatory requirements (FDA, EU, ICH).
- Ability to assess risks and ensure adherence to quality systems.
- Experience managing timelines, resources, and deliverables.
- Proficiency in MS Office, engineering software, and electronic document management systems.
