Senior Manufacturing Engineer Job at Pharmaceutical Company, Somerville, NJ

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  • Pharmaceutical Company
  • Somerville, NJ

Job Description

As a Senior Manufacturing Engineer , you’ll play a key role in advancing diagnostic production processes, ensuring top quality, efficiency, and automation excellence.

Key Responsibilities:

  • Design, install, and qualify new automated filling and packaging equipment
  • Define equipment specifications and support validation (IQ/OQ/PQ)
  • Lead cross-functional projects to improve throughput, yield, and equipment uptime
  • Develop and maintain manufacturing documentation (SOPs, records, specs)
  • Drive process optimization, cost reduction, and continuous improvement initiatives
  • Ensure compliance with cGMP , ISO , and FDA standards

Qualifications:

  • Bachelor’s or Master’s in Engineering or related field
  • 4–6+ years of experience in a cGMP manufacturing or medical device/diagnostics environment
  • Hands-on experience with automation, packaging, and equipment validation
  • Strong knowledge of design transfer , process optimization , and cross-functional collaboration
  • Experience with injection molding , adhesive bonding , or surface treatments a plus

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