PROJECT ENGINEER
Position Summary:
The Project Engineer is responsible for safely leading and coordinating projects related to New Product Introductions, Process Improvements, Automation, Aseptic Processing, and New Processing Equipment—including associated Facility/Utility modifications. The role ensures projects are delivered on time, within budget, and meet defined scope and quality targets. The Project Engineer reports to the Senior Manager of Aseptic Engineering and collaborates closely with cross-functional teams.
Key Responsibilities:
* Safely lead cross-functional teams for the delivery of processing equipment such as Autoclaves, RABS & Isolator Filling Machines, LAF Units, Compounding Skids, Vessels, Containment Booths, and Stopper Processing Equipment.
* Prepare and manage User Requirement Specifications (URS) and vendor selection processes, including evaluation matrices.
* Generate RCEs, place equipment orders, and conduct project management/design review meetings.
* Apply ASME BPE 2019 standards and relevant ISPE guidelines.
* Oversee equipment installation, service hook-ups, and coordinate with vendors and site engineering teams.
* Lead Factory Acceptance Testing (FAT) and manage documentation for equipment commissioning and qualification.
* Collaborate with project stakeholders on training, O&M manuals, spare parts lists, and preventive maintenance schedules.
* Contribute to technical problem-solving forums related to product manufacturing and aseptic fill processes.
* Drive process improvement and cost reduction initiatives.
* Conduct weekly or bi-weekly project review meetings and participate in Tier 1 meetings with management.
Qualifications & Skills:
* Bachelor's degree in Engineering or equivalent experience.
* 2–5 years of experience in Biologics, Pharmaceutical, or Medical Device industries.
* Proven project management skills with technical proficiency.
* Strong communication, interpersonal, and team leadership abilities.
* Self-starter with the ability to work independently and cross-functionally.
* Experience delivering project goals in a multidisciplinary environment.