Manufacturing Engineer
Job in
Lawrence, Essex County, Massachusetts, 01842, USA
Listed on 2026-03-09
Listing for:
United Pharma Technologies Inc
Full Time
position Listed on 2026-03-09
Job specializations:
-
Manufacturing / Production
Validation Engineer, Manufacturing Engineer, Quality Engineering, Medical Device Industry
Job Description & How to Apply Below
We are looking for Manufacturing Engineers to support the installation, commissioning, and qualification of new manufacturing equipment for a newly established production line. This is a hands‑on, onsite role focused on bringing new equipment from installation through IQ (Installation Qualification) to support a critical product launch.
The ideal candidate will have strong experience in regulated medical device manufacturing environments and be comfortable working cross‑functionally with quality, validation, and commissioning teams.
Key Responsibilities- Lead and support the installation and commissioning of new manufacturing equipment.
- Partner with Quality, Validation, and Engineering teams to transition equipment from installation through the IQ phase.
- Develop and author User Requirement Specifications (URS).
- Create and execute Installation Qualification (IQ) protocols.
- Perform onsite qualification activities and ensure compliance with regulatory standards.
- Troubleshoot equipment issues during commissioning and qualification phases.
- Support documentation in accordance with FDA and GMP requirements.
- Contribute to the successful launch of a new production line.
- Collaborate with vendors and internal stakeholders to ensure equipment meets performance and regulatory expectations.
- Hands‑on experience with installation, commissioning, and qualification of manufacturing equipment.
- Proven ability to author and execute URS and IQ protocols.
- Prior experience in a Medical Device manufacturing environment.
- Strong understanding of GMP and regulatory documentation standards.
- Ability to work independently in a fast‑paced, onsite setting.
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