Project Engineer (Aseptic Processes)
The Project Engineer is responsible for safely coordinating and leading projects associated with process improvements, automation, aseptic processing, and new processing equipment with facility and utilities modifications.
Responsibilities
* Safely coordinate and lead cross-functional project teams for the delivery of processing equipment to the site based on planned timelines and scope.
* Write user requirement specifications.
* Select vendors and complete vendor evaluation matrices.
* Write request for change reports, place orders, and conduct project management and design review meetings.
* Work in accordance with ASME BPE 2019 standards and relevant ISPE guidelines.
* Coordinate processing equipment installation and services hook-up, working with equipment vendors and engineering personnel.
* Lead project team participation in factory acceptance testing programs.
* Coordinate all equipment documentation requirements.
* Commission equipment and provide engineering support during qualification.
* Collaborate with the E&T senior manager and system owner/project team.
* Handover training, coordination of O&M manuals, spare parts, and PM schedules.
* Contribute to technical problem-solving forums associated with product manufacture and aseptic fill.
* Deliver process improvement/cost reduction projects.
* Lead weekly/bi-weekly project review meetings with the project team.
Key Requirements
* Third-level qualification in an engineering or equivalent discipline/experience.
* Experience in biologics, pharmaceuticals, or medical device industries.
* Minimum of 2-5 years' experience.
* Project management experience with a proven record.
* Ability to work within a team using own initiative to articulate and deliver specific functional requirements for all aspects of the project.
* Good team leading skills and ability to work closely with other areas/departments within an organization.