Job Title:
Aseptic Processing Engineer
Overview:
The Aseptic Processing Engineer plays a pivotal role in ensuring the successful delivery of projects related to New Product Introductions, Process Improvements, Automation, Aseptic Processing, and New Processing Equipment. This includes associated Facility/Utility modifications.
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.