Jobs · Quality Assurance · Massachusetts

Equipment Validation Engineer

Stark Pharma Solutions Inc · Boston, MA · 1 mo ago
On-siteQuality AssuranceContract

About the role

We are looking for an Equipment Validation Engineer to support equipment validation activities in a medical device manufacturing environment.

Responsibilities

  • Perform IQ/OQ/PQ activities for new and existing equipment.
  • Support equipment installation and calibration.
  • Support equipment qualification and commissioning.
  • Prepare and maintain validation documents.
  • Create and update SOPs and equipment records.
  • Prepare risk assessments and safety documents.
  • Create equipment safety procedures and training manuals.
  • Work with Manufacturing, Quality, Engineering, and EHS teams.
  • Support equipment validation activities on the manufacturing floor.
  • Ensure equipment activities meet quality and regulatory requirements.

Requirements

  • Bachelor’s degree in Engineering or related field.
  • 5+ years of equipment validation experience.
  • Strong knowledge of IQ/OQ/PQ.
  • Experience with equipment installation and calibration.
  • Experience with equipment qualification and commissioning.
  • Knowledge of EHS standards and risk assessments.
  • Strong technical writing and documentation skills.
  • Experience with SOPs and training documentation.
  • Strong communication and teamwork skills.

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