Project Execution Expert
Job Summary:
We are seeking a seasoned Project Manager to lead cross-functional teams in delivering processing equipment such as Autoclaves, RABS & Isolator Filling Machines, LAF Units, Compounding Skids, Vessels, Containment Booths, and Stopper Processing Equipment. The ideal candidate will have experience in Biologics, Pharmaceutical, or Medical Device industries with strong project management skills and technical proficiency.
Main Responsibilities:
* Lead cross-functional teams in the delivery of processing equipment including preparation and management of User Requirement Specifications (URS) and vendor selection processes.
* Generate Requests for Capital Expenditures (RCEs), place equipment orders, and conduct project management/design review meetings.
* Apply ASME BPE standards and relevant ISPE guidelines throughout the project lifecycle.
* 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, Operations and Maintenance manuals, spare parts lists, and preventive maintenance schedules.
* Contribute to technical problem-solving forums related to product manufacturing and aseptic fill processes.
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.