Job Title

Ensures the site operates in compliance with regulatory standards that ensures product quality, avoids stoppages, and reinforces customer happiness.

What will you do?

Work with a dedicated group of people to provide innovative solutions for our internal and external clients.
Support the site CAPEX team with working with vendors to craft and implement new manufacturing equipment for a Steriles manufacturing facility.
Understand how new and existing manufacturing equipment interacts with the surrounding facility, rooms, and utilities.
Work with the Operations, Maintenance, Project Engineering, Automation, Validation, and Quality teams as needed to complete projects.
Collaborate with equipment vendors to draft User Requirements Specifications, design new equipment, oversee installation, conduct Factory Acceptance Testing, Site Acceptance Testing, Commissioning, and Start Up.
Assist the Operations team in improving Steriles manufacturing line efficiency through equipment upgrades.
Familiarize yourself with current Steriles manufacturing equipment regulations. Identify and implement necessary upgrades.
Assist in Tech Transfer for new products on commercial lines by coordinating with vendors for ordering, receiving, and testing parts needed to run components.
Perform and own any change control records associated with Process Engineering led equipment upgrades and modifications.
Ensure familiarity with industry equipment design and compliance standards.
Draft and complete Engineering study documents, testing, and data summaries assigned.

Education

Undergraduate or Graduate degree in Engineering either completed or enrolled in Engineering Degree program and on track to graduate in May 2026 (Mechanical, Electrical, Bio-medical, Chemical, or related field).

Equivalent combinations of education, training, and relevant work experience may be considered.

Effective verbal and written communication skills (legible writing)
Effective time management and prioritization skills.
Outstanding attention to detail and organizational skills.
Self-starter, mature, independent, and diligent.
Ability to work in a fast-paced environment under pressure, able to multi-task.
Ability to respond disciplined and rationally under pressure.
Requires discretion and independent judgment.
Excellent communication skills to establish and maintain effective working relationships with internal engineers.
Multiple digital literacy including working experience with MS Office applications such as Word and Excel.

Requires basic mobility; standing, walking, kneeling, lifting light to medium weights; using hands for typing; good vision and hearing.