Commissioning & Qualification Specialist
This is an exciting opportunity to work on state-of-the-art pharmaceutical systems and make a real impact in a fast-paced GMP environment.
Key Responsibilities:
* Generating, executing, and approving qualification documents for Direct Impact Systems (Facility, Utility, Equipment).
* Creating Commissioning Test documents for Non-Direct Systems.
* Ensuring all systems meet cGMP and cGDP standards and project timelines.
We are looking for a highly skilled Commissioning & Qualification Specialist with:
* BS Degree in Engineering, Science, or a technical discipline.
* 3+ years of Commissioning & Qualification experience, preferably in OSD or pharmaceutical settings.
* Experience with clean utility tie-ins, sanitary equipment, hygienic piping, process instrumentation, and controls.
* Knowledge of risk-based commissioning and qualification approaches.
* Familiarity with project management tools.
Desirable Skills:
* Strong technical writing skills and experience working in a GMP-regulated environment.
* Ability to work independently, demonstrate teamwork, and adapt to project demands.
* Systems Experience: Facility/Qualification systems Dispensing equipment (down flow booths, matcom stations, PTS powder systems) Tumble mixer equipment, including CIP skid Utilities such as compressed air systems.
Why You'll Thrive:
* Opportunity to work with cutting-edge technology.
* Collaborative team environment.
* Chance to grow professionally and personally.
What We're Looking For:
* Passion for delivering high-quality results.
* Excellent communication and interpersonal skills.
* Ability to prioritize tasks and manage multiple projects.