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Company

Original Job Post

Novartis · 2 days ago

Commissioning & Qualification (C&Q) Engineering Lead

United States

Full-time

Remote

Senior Level

$124K/yr - $186K/yr

5+ years exp

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Responsibilities

Lead site C&Q planning by writing and maintaining master plans for projects and the site.

Maintain the site process control strategy.

Draft CQV and CSV activities for production and manufacturing equipment.

Support ongoing qualification activities such as VHP qualification, smoke studies, temperature mapping, and room qualification.

Design, execute, and document experiments for process transfer, improvement, and validation.

Prepare and review appropriate GxP documentation including change requests.

Identify improvement options of current processes and propose business cases.

Qualification

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GMPCQVValidation ProjectsAseptic ManufacturingTechnical ReportsProblem-SolvingLeadershipChemical EngineeringMechanical Engineering

Required

Bachelors degree is required; Masters Degree is preferred. Prefer concentration in Chemical or Mechanical Engineering.

5+ years’ experience of relevant experience in a GMP pharma environment is required.

Experience in executing CQV, having led and managed validation projects is required.

Direct experience in an aseptic manufacturing setting is highly preferred.

Expert in reviewing and writing technical reports.

Preferred

Masters Degree is preferred. Prefer concentration in Chemical or Mechanical Engineering.

Benefits

401(k) eligibility

Various paid time off benefits, such as vacation, sick time, and parental leave

Company

Novartis

Glassdoor

3.9

Novartis is a healthcare company that provides solutions to address the evolving needs of patients worldwide.

Founded in 1996

Basel, Basel-Stadt, CHE

10,001+ employees

https://www.novartis.com

H1B Sponsorship

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