Process Engineering Lead
The Senior Process Engineer will play a key role in ensuring the smooth operation of our automated Pen Needle production process. This involves leading a team of engineers and technicians to support production and maintenance, resolving daily issues and troubleshooting.
Responsibilities include utilizing a data-driven approach to investigate and resolve process issues, driving structured problem-solving with technicians. Additionally, they will review preventive maintenance schedules regularly to ensure effectiveness in reducing equipment failure and enhancing uptime.
Other responsibilities include collaborating with material suppliers to match machine and process capabilities, ensuring robust controls across the value chain to maintain process stability and equipment uptime. They will also coordinate with the development team on new equipment or processes to establish robust process windows and ensure effective handover to production.
The Senior Process Engineer will lead investigations into QN, Customer Complaints, and CAPA issues. They will manage change control processes within the assigned area, ensuring proper documentation and approvals. Furthermore, they will train and develop technicians in the process engineering area.
Maintaining a safe working environment is crucial, so the Senior Process Engineer will ensure safety in all activities and conduct risk assessments for new and existing tasks. Compliance with the Business Quality Policy is also essential, as is conducting performance reviews, setting objectives, and managing 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 Value Diversity and Inclusion
We are an Equal Opportunity/Affirmative Action 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.