Process Engineer

Work set-up: 
Hybrid
Work from: 
Keene (US)

Katalyst HealthCares & Life Sciences logo
Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/
51 - 200 Employees
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Job description

Responsibilities:
  • Develop new process for siliconization of syringe plunger tips.

  • Experiments with legacy equipment to justify elimination of bonding agent and define process output requirements.

  • Design verification samples.

  • Development of process for new equipment.

  • Validation of new equipment and process.

  • Support Keene production with sustaining project execution.

  • Support design reviews, debug, acceptance, and validation activities for equipment being developed by external suppliers.

Requirements:

  • 4+ years' experience in a medical device manufacturing environment.

  • Process development experience.

  • Validation experience: IQ, OQ, PQ and TMVs .

  • Strong background in statistical methods: DOEs, GR&Rs & Process Capability.

  • Familiarity with standard MS Office tools.

  • Good verbal and written communication skills.

Required profile

Experience

Industry :
Pharmaceuticals

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