Validation Engineer

Novozen Healthcare LLC

Oregon

Híbrido

USD 96.000 - 152.000

Jornada completa

hace 23 horas
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Ventajas ofrecidas por este puesto de trabajo

Health Insurance
401(k) Retirement Plan
PTO

Descripción de la vacante

Novozen Healthcare LLC in Oregon seeks a Validation Engineer – Temperature Mapping on a 9-month contract. You will support GMP environments, perform thermal validation, and maintain CQ documentation while collaborating with cross-functional teams.

Experience with DeltaV and Historian, plus CQ activities and strong documentation skills, are required. Remote work is available initially with on-site travel as needed; health benefits and a 401(k) are offered where eligible.

Formación

  • 5+ years of validation and qualification experience in pharmaceutical/biotech environments.
  • Strong hands-on experience in temperature mapping and thermal validation.
  • Experience with Commissioning & Qualification (C&Q) activities.
  • Previous experience in GMP-regulated environments.
  • Familiarity with electronic validation execution systems.
  • Knowledge of DeltaV and Historian systems.
  • Strong documentation, communication, and coordination skills.

Responsabilidades

  • Support temperature mapping planning, preparation, and execution within GMP environments.
  • Perform thermal validation and temperature mapping activities.
  • Prepare, review, and maintain validation and qualification documentation.
  • Ensure all validation activities comply with GMP requirements and industry standards.
  • Utilise electronic validation execution systems to support validation documentation and execution.
  • Work with DeltaV and Historian systems as required.
  • Collaborate with cross-functional teams to support validation and qualification activities.

Conocimientos

Validation & Qualification expertise
GMP know-how
Documentation & coordination

Herramientas

DeltaV
Historian

Descripción del empleo

Job Title: Validation Engineer – Temperature Mapping

Location: Oregon (Remote initially; occasional on-site travel required)

Employment Type: Contract (9 Months)

Job Responsibilities
  • Support temperature mapping planning, preparation, and execution within GMP-regulated environments.
  • Perform thermal validation and temperature mapping activities.
  • Prepare, review, and maintain validation and qualification documentation.
  • Ensure all validation activities comply with applicable GMP requirements and industry standards.
  • Utilise electronic validation execution systems to support validation documentation and execution.
  • Work with DeltaV and Historian systems as required.
  • Collaborate with cross-functional teams to support validation and qualification activities.
Work Schedule:
  • January – March: Approximately 25% utilisation, primarily focused on remote planning, documentation, and occasional on-site travel.
  • April – September: Approximately 80–100% utilisation, primarily focused on on-site execution activities.
Required Qualifications
  • 5+ years of experience in validation and qualification within pharmaceutical or biotechnology environments.
  • Strong hands‑on experience in temperature mapping and thermal validation.
  • Experience with Commissioning & Qualification (C&Q) activities.
  • Previous experience working in GMP-regulated environments.
  • Familiarity with electronic validation execution systems.
  • Knowledge of DeltaV and Historian systems.
  • Strong documentation, communication, and coordination skills.

Anticipated hourly pay range: Open / Negotiable based on experience and qualifications.

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 pay 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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