Senior Process Engineer Job Summary
About the Role
The Senior Process Engineer will lead a team of technicians in a fast-paced, automated Pen Needle production process. This position owns process performance, driving improvements in quality, uptime, and efficiency.
Key Responsibilities:
* Lead a team of engineers and technicians to support production and maintenance, resolving daily issues and troubleshooting.
* Investigate and resolve process issues using a data-driven approach, driving structured problem-solving with technicians.
* Review preventive maintenance schedules regularly to ensure effectiveness in reducing equipment failure and enhancing uptime.
* Collaborate with material suppliers to match machine and process capabilities, ensuring robust controls across the value chain to maintain process stability and equipment uptime.
* Coordinate with the development team on new equipment or processes to establish robust process windows and ensure effective handover to production.
* Conduct investigations into QN, Customer Complaints, and CAPA issues.
* Manage change control processes within the assigned area, ensuring proper documentation and approvals.
* Train and develop technicians in the process engineering area.
* E nsure safety in all activities and conduct risk assessments for new and existing tasks.
* Ensure compliance with the Business Quality Policy.
* Conduct performance reviews, set objectives, and manage absence for direct reports.
Requirements:
* Bachelor's Degree in Engineering.
* Minimum of 10 years of process engineering experience with people management.
* Strong data analysis skills and experience with Six Sigma or similar problem-solving methodologies.
* Knowledge of Lean techniques: Standard Work, TPM.
* Experience with equipment validation and documentation in a regulated industry is a plus.
We are an Equal Opportunity Employer. We do not discriminate unlawfully based on race, color, religion, age, sex, creed, national origin, ancestry, citizenship, marital or domestic status, sexual orientation, gender identity, genetics, disability, military status, or veteran status.