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Intertwined

Validation Engineer (GMP Pharmaceutical)

Full Time
Bethlehem, PA, USA
Description

The Denzel Group, an award-winning search firm, has been chosen to work with a global leader on their quest for a talented Packaging Validation Engineer. In this role you will be meeting with customers to understand requirements, writing protocols, overseeing execution on the floor, and creating reports. These activities are related to equipment, process, computers and facilities for commercial packaging.


Responsibilities

  • Generate and execute validation protocols, as well as qualifications for design, installation, operations and performance.

  • Conduct quality engineering reviews of design documentation.

  • Ensure compliance with Good Validation Practices and cGMP.

  • Support key internal stakeholders on validation regarding new equipment, process, and systems

  • Support customer audits and regulatory inspections.

  • Write and manage SOPs related to validation processes and equipment.

  • Write Confirmation of Changes for equipment, systems, and processes.

Requirements
  • 5+ years’ GMP validation or engineering experience in a medical device, pharmaceutical, clinical, or R&D environment.

  • Technical Writing experience of SOPs.


To apply please send your application to mschroeder@thedenzelgroup.com


#IND1


validation, GMP, medical device, pharma, clinical, R&D, packaging, write, protocols, SOP, qualification, Engineer, analyst

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