Job Description:
This role involves working in a sterile environment supporting technical transfers and delivering projects under continuous improvement.
We are seeking a highly skilled Process Engineer to join our team. As a key member of our operations department, you will be responsible for delivering process improvements in thawing, formulation, filling, filter integrity testing, and wash/autoclave areas to support new product introduction and capacity expansion.
Main Responsibilities:
* Deliver process improvements through cycle development protocol/reports, project improvements, deviations, problem solving, and change controls.
* Execute Process Engineering activities to schedule and ensure compliance with safety standards.
* Support commercial manufacturing through delivery of key performance metrics (SQDCI).
* Participate in regulatory audits to ensure adherence to industry regulations.
Requirements:
To succeed in this role, you must possess the following skills and qualifications:
* Degree in an engineering discipline.
* Strong problem-solving skills.
* Excellent documentation and protocol generation skills.
* A minimum of 3-5 years of relevant experience in a highly regulated GMP environment.
* Experience in syringe filling is highly advantageous.
* Ability to lead major investigations and troubleshoot complex problems.
* Familiarity with weight cycle development for filling machines and new product introduction to sterile manufacturing.