Job Description:
As a Process Development Engineer, you will play a key role in shaping the trajectory of our company while leaving a lasting legacy.
Main Responsibilities
* Develop and implement manufacturing processes for new products, ensuring efficiency and effectiveness.
* Collaborate with cross-functional teams to track project status and follow up on action items.
* Communicate with suppliers to determine product process and equipment specifications.
* Supervise or manage technicians, engineers, and interns.
* Document process development, including manufacturing procedures, protocols, and reports.
* Estimate resource requirements, workload assignment, production times for manufacturing processes.
* Train operations and quality assurance staff on new design and process development methods.
* Manage site selection based on internal sites, suppliers, and contract manufacturers.
About This Opportunity:
* Bachelor's degree in an engineering discipline is essential.
* 4+ years of industrial experience in process development, preferably in a regulated environment.
* Hands-on technical knowledge with cGMP and GLP expertise.
* Working knowledge of DOE and statistical methods.
* Strong written, communication, and interpersonal skills.
* Ability to analyze data, interpret results, and write reports.
* Experience in Six Sigma or Design for Six Sigma.
* Training in technology transfers.
* Process validation (IQ, OQ, PQ) experience is an advantage.
* PMO certification is also beneficial.