Job Title: Senior Process Engineer
Job Overview:
We are seeking a highly experienced Senior Process Engineer to join our Manufacturing Technology team. As a key member of this team, you will be responsible for providing engineering support to the ongoing requirements for manufacturing operations and supporting future technology transfer projects.
Main Responsibilities:
* Assist in site start-up and project-related activities, ensuring seamless integration with existing systems.
* Support package owners on vendor management and equipment or process-related activities and queries, providing expert guidance and recommendations.
* Develop and implement equipment verification & validation protocols and reports as required, guaranteeing compliance with industry standards.
* Review vendor documentation for completeness and accuracy, identifying areas for improvement and implementing changes.
* Participate in Factory Acceptance Testing (FAT) and vendor-related activities, ensuring that all equipment meets quality and safety standards.
* Support issue resolution during equipment installation, commissioning, and qualification phases, minimizing downtime and maximizing productivity.
Requirements:
* Third-level qualification in a Science or Engineering related subject is highly desirable.
* Minimum of 8 years experience in a large-scale biopharmaceutical/pharmaceutical facility, preferably in a leadership or senior technical role.
* Excellent communication skills, including computer literacy and ability to work independently and in a team environment.
* Thorough knowledge of current Good Manufacturing Practices (cGMP), with a strong understanding of regulatory requirements.
* Experience and knowledge of DeltaV MCS platform is highly preferred.
* Familiarity with Chromatography and Ultra filtration production operations is an advantage.