Validation Engineer – Temperature Mapping

Novozen Healthcare LLC

Portland (OR)

Presencial

USD 69.000 - 83.000

Jornada completa

hace 27 horas
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Ventajas ofrecidas por este puesto de trabajo

Health Insurance
401(k) Retirement Plan
Paid Time Off (PTO)

Descripción de la vacante

Novozen Healthcare LLC is seeking a Contract Validation Specialist to support qualification activities in GMP-regulated pharmaceutical environments in Portland, Oregon.

The role emphasizes temperature mapping, thermal validation, and CQ&Q execution with DeltaV, Historian, and electronic validation systems. You will prepare, review, and finalize documentation, ensure GMP compliance, and coordinate planning and on-site execution with remote support as needed.

Formación

  • 5–8+ years of experience in validation and qualification within pharmaceutical or biotechnology industries.
  • Strong hands-on experience in temperature mapping and thermal validation.
  • Proven experience in Commissioning & Qualification (C&Q).
  • Experience working in GMP-regulated environments.
  • Familiarity with electronic validation execution systems.
  • Knowledge of DeltaV and Historian systems.
  • Preferred experience with eLab and ValGenesis.

Responsabilidades

  • Support temperature mapping planning, execution, and thermal validation activities within GMP-regulated environments.
  • Prepare, review, and execute validation and qualification documentation.
  • Ensure compliance with GMP requirements and applicable regulatory standards.
  • Support activities involving DeltaV and Historian systems.
  • Coordinate remote planning, documentation, and onsite execution activities as required.

Conocimientos

Temperature mapping
Thermal validation
GMP compliance
C&Q experience
Electronic validation systems

Herramientas

DeltaV
Historian
eLab
ValGenesis

Descripción del empleo

Employment Type: Contract – 9 Months

Job Responsibilities
  • Support temperature mapping planning, execution, and thermal validation activities within GMP-regulated environments.
  • Prepare, review, and execute validation and qualification documentation.
  • Ensure compliance with GMP requirements and applicable regulatory standards.
  • Support activities involving DeltaV and Historian systems.
  • Coordinate remote planning, documentation, and onsite execution activities as required.
Required Qualifications
  • 5–8+ years of experience in validation and qualification within pharmaceutical or biotechnology industries.
  • Strong hands-on experience in temperature mapping and thermal validation.
  • Proven experience in Commissioning & Qualification (C&Q).
  • Experience working in GMP-regulated environments.
  • Familiarity with electronic validation execution systems.
  • Knowledge of DeltaV and Historian systems.
  • Preferred experience with eLab and ValGenesis.
Pay Scale

Anticipated hourly pay range: $50–$60 per hour on W-2.

Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements.

Health Insurance:

Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits:

A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO):

No PTO other than that required by applicable state and local laws.

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