Mechanical Project Engineer

Company : Katalyst HealthCares & Life Sciences

Location : Columbus, OH, 43224

Posted Date : 2 October 2025

Job Type : Other

Category : Project Management

Occupation : Project Engineer

Job Details

Job Description:

New packaging line and they need a Systems Owner/Mechanical Project Engineer.
We are seeking a highly skilled System Owner with a background in Mechanical Project Engineering to support the installation and qualification of a new secondary packaging line at a leading pharmaceutical manufacturer.
This is a 12-month contract role offering the opportunity to manage the technical and documentation aspects of a major capital project in close coordination with corporate engineering, vendors, and site stakeholders.
This project builds on an existing line, providing a well-defined template for success while requiring strong engineering oversight and vendor management expertise.

Responsibilities:

Serve as System Owner for equipment related to the new secondary packaging line.
Review and ensure vendor equipment design, specifications, and documentation meet FDA and Client standards and project requirements.
Collaborate with vendors directly to address and resolve design or documentation issues.
Partner with corporate engineering on equipment procurement, specifications, and alignment with global standards.
Support C&Q (Commissioning & Qualification) of equipment, including site acceptance testing and installation oversight.
Lead and support quality risk assessments, spare part procurement planning, and equipment design reviews.
Manage project timelines, ensuring deliverables are met efficiently and risks are mitigated.
Conduct thorough document reviews (specifications, assembly documentation, vendor deliverables) for accuracy and compliance; minimal authoring required.
Provide technical oversight and act as liaison between site operations, engineering, and quality functions.

Requirements:

5+ years of pharmaceutical or biotech industry experience with a strong focus on capital projects, equipment design, or packaging line installations.
Proven experience managing vendor interactions, equipment procurement, and installation projects.
Hands-on involvement in C&Q activities and site acceptance testing for packaging or process equipment.
Familiarity with GMP, quality risk management, and technical documentation review.
Strong organizational, communication, and cross-functional collaboration skills.
Ability to manage competing priorities and ensure alignment across corporate engineering, vendors, and site operations.