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Commissioning & Qualification Engineer
Commissioning & Qualification EngineerStark Pharma Solutions Inc • CA, United States
Commissioning & Qualification Engineer

Commissioning & Qualification Engineer

Stark Pharma Solutions Inc • CA, United States
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Position : Commissioning & Qualification Engineer

Location : Los Angeles, CA (Onsite)

Experience : 3 10 Years

Duration : 12+ Months

NOTE : Local candidates preferred

Position Overview

We're looking for a skilled Commissioning & Qualification Engineer to support a long-term pharmaceutical facility project. This is a Contract onsite role requiring close coordination with construction and validation teams, as well as daily site walks in full PPE.

Key Responsibilities

Execute Facilities CQV activities, including EMPO, Vessel IOV, and IOPQ (mixing and temperature mapping).

Support commissioning and qualification of process equipment such as centrifuges, filter presses, and processing tanks .

Perform installation qualification (IQ) and operational qualification (OQ) of equipment and systems.

Conduct job walks at the construction site with engineering teams to monitor progress and compliance.

Collaborate with cross-functional teams to ensure project timelines and quality standards are met.

Generate, review, and maintain technical documentation for CQV deliverables.

Provide additional support for systems such as Utilities (WFI, Alcohol, N , Compressed Air) , CIP , Filter Press , Centrifuge , and Cleaning Validation as needed.

Maintain high safety standards while performing daily activities in a regulated environment.

Qualifications

Bachelor's degree in Engineering or a related field.

3 10 years of experience in Validation or CQV within the pharmaceutical industry .

Strong knowledge of facilities and process equipment validation .

Cleanroom qualification experience is a plus.

Excellent technical writing and documentation skills.

Strong communication, organization, and multitasking abilities.

Experience supporting capital projects and conducting job walks .

Must be flexible to support other shifts on short notice as required.

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Commissioning Engineer • CA, United States

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